| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K001600 |
11/22/2000 |
CODA INCUBATOR CELLMATE |
INTL., INC. |
MICHAEL D CECCHI |
| K000654 |
11/14/2000 |
VBMAX |
A-M SYSTEMS, INC. |
STEVE GRASSER |
| K002986 |
11/29/2000 |
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 |
A.R.C. LASER AG |
DANIEL HOEFER |
| K002139 |
11/08/2000 |
ETEST LINEZOLID |
AB BIODISK |
ANNE BOLMSTORM |
| K001993 |
11/13/2000 |
SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS |
ABBOTT LABORATORIES |
JOE MAGLIOZZI |
| K001044 |
11/03/2000 |
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM |
ACME SPINE, LLC. |
TIMOTHY WILLIAMS |
| K003434 |
11/16/2000 |
ALLEGRO TB, ALLEGRO N |
ADAC LABORATORIES |
DAVID KOLESAR |
| K001510 |
11/30/2000 |
OS-2000 OPTICAL SONOGRAPHY SYSTEM |
ADVANCED DIAGNOSTICS, INC. |
STEVE HESLER |
| K002573 |
11/16/2000 |
ADVANCED UROSCIENCE INNERSHEATH |
ADVANCED UROSCIENCE, INC. |
KAREN E PETERSON |
| K002459 |
11/08/2000 |
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH |
AGILENT TECHNOLOGIES, INC. |
ROB BUTLER |
| K003370 |
11/22/2000 |
JAMSHIDI MARROW ACQUISITION CRADLE |
ALLEGIANCE HEALTHCARE CORP. |
LAVENIA FORD |
| K003109 |
11/21/2000 |
COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
ALLERGAN, INC. |
PAUL J NOWACKI |
| K001520 |
11/22/2000 |
ALPHA OMEGA DUAL COOLER-HEATER |
ALPHA OMEGA, INC. |
RICHARD MARTIN |
| K002709 |
11/17/2000 |
RACE ENDODONTIC FILE |
AMC GENERAL, INC. |
RAY T BURKE |
| K002447 |
11/16/2000 |
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K002721 |
11/29/2000 |
AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH |
AMERICAN MEDICAL SYSTEMS, INC. |
GINGER Z GLASER |
| K002503 |
11/09/2000 |
FETALGARD LITE |
ANALOGIC CORP. |
STEVEN A CLARKE |
| K992493 |
11/06/2000 |
VIPON TAMPON |
ANOTHERWAY PRODUCTS LLC. |
STEVEN A KILGORE |
| K002644 |
11/20/2000 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K001651 |
11/22/2000 |
BIO-RAD %CDT TIA |
AXIS-SHIELD BIOCHEMICALS, ASA |
RONALD G LEONARDI |
| K003193 |
11/07/2000 |
DUPLOGRIP |
BAXTER HEALTHCARE CORP. |
ARLENE VIDOR |
| K001685 |
11/15/2000 |
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K002938 |
11/29/2000 |
B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
PETER ZURLO |
| K003098 |
11/20/2000 |
ACCESS ULTRASENSITIVE HGH CALIBRATORS |
BECKMAN COULTER, INC. |
MARA CALER |
| K003488 |
11/27/2000 |
SYNCHRON CONTROL |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K002456 |
11/02/2000 |
MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 |
BECTON DICKINSON VACUTAINER SYSTEMS |
James Haynes |
| K003239 |
11/30/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 |
BIO-RAD |
ELIZABETH PLATT |
| K003242 |
11/30/2000 |
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 |
BIO-RAD |
ELIZABETH PLATT |
| K003030 |
11/29/2000 |
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET |
BIO-RAD |
ELIZABETH PLATT |
| K003294 |
11/03/2000 |
BIOMET LATERAL TROCH PLATE |
BIOMET, INC. |
TRACY J BICKEL |
| K003296 |
11/06/2000 |
BIOMET SCK KNEE SYSTEM |
BIOMET, INC. |
TRACY J BICKEL |
| K003428 |
11/24/2000 |
ISS OFFSET HEADS |
BIOMET, INC. |
DALENE T BINKLEY |
| K003429 |
11/30/2000 |
MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL |
BIOMET, INC. |
DALENE T BINKLEY |
| K003131 |
11/02/2000 |
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT |
BIOMET, INC. |
CAROL LAUSTER |
| K002757 |
11/24/2000 |
ONCOLOGY SALVAGE SYSTEM |
BIOMET, INC. |
TINA LAKIN |
| DEN000010 |
11/20/2000 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST |
BIOSITE INCORPORATED |
JEFF DAHLEN |
| K003317 |
11/21/2000 |
RENEW LS-1 |
BISCO, INC. |
CINDY ORIS |
| K003361 |
11/28/2000 |
RENEW LS-2 |
BISCO, INC. |
CYNDY ORIS |
| K002509 |
11/03/2000 |
NOVALIS (SHAPED BEAM SURGERY SYSTEM) |
BRAINLAB AG |
STEFAN VILSMEIER |
| K002263 |
11/27/2000 |
BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K002272 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K002266 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002337 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002342 |
11/27/2000 |
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002264 |
11/27/2000 |
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002417 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, MODEL 190C AND 190D |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002587 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002265 |
11/27/2000 |
BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002268 |
11/27/2000 |
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002418 |
11/22/2000 |
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K002499 |
11/08/2000 |
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
GLEN MIZELLE |
| K002421 |
11/03/2000 |
CANDELA MID IR DIODE LASER SYSTEM |
CANDELA CORP. |
JOAN CLIFFORD |
| K003220 |
11/08/2000 |
PERSONAL ECG TRANSMITTER, MODEL CG-6550 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
LEONID TRACHTENBERG |
| K991783 |
11/01/2000 |
AB-180 XC SYSTEM, MODEL AB-180XC |
CARDIAC ASSIST, INC. |
RICHARD G CONFER |
| K002597 |
11/17/2000 |
CN ACQUISITION STATION |
CARDIONOW, INC. |
JOHNNY M GARZA |
| K002792 |
11/08/2000 |
CARESIDE CHOLINESTERASE |
CARESIDE, INC. |
KENNETH B ASARCH |
| K002693 |
11/09/2000 |
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) |
CBS INTL. B.V. |
PATRICIA E JANSEN |
| K002493 |
11/30/2000 |
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K003034 |
11/30/2000 |
COLTENE AURA COMPOMER RESTORATIVE SYSTEM |
COLTENE/WHALEDENT INC. |
H. J VOGELSTEIN |
| K003217 |
11/03/2000 |
HERMES PORT EXPANDER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K003222 |
11/03/2000 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K003213 |
11/29/2000 |
ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS |
CONCEPT RUBBER PRODUCTS SDN BHD |
TEOH HUN LIM |
| K001249 |
11/02/2000 |
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 |
CONSOLIDATED TECHNOLOGIES OF WISCONSIN |
RUSTY SEWELL |
| K002288 |
11/28/2000 |
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER |
COOK, INC. |
APRIL LAVENDER |
| K000651 |
11/24/2000 |
DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM |
COOK, INC. |
LISA WEBB |
| K003336 |
11/22/2000 |
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA S JUGO |
| K003365 |
11/22/2000 |
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) |
CORDIS CORP. |
SAM MIRZA |
| K002595 |
11/17/2000 |
CBS STRAW |
CRYO BIO SYSTEM |
GABRIELE LINGENOLELE |
| K002584 |
11/16/2000 |
ECAT ACCEL PET SCANNER |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
| K002080 |
11/16/2000 |
BEHRING COAGULATION SYSTEM, MODEL BCS |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K002731 |
11/20/2000 |
N LATEX B2-MICROGLOBULIN |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K002852 |
11/27/2000 |
N/T PROTEIN CONTROL SL |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K000004 |
11/29/2000 |
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 |
DAIG CORP. |
PAUL CORNELISON |
| K003235 |
11/06/2000 |
PE.R.I. II KNEE FRACTURE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K003146 |
11/21/2000 |
CLINIFLO INCENTIVE SPIROMETER |
DHD HEALTHCARE CORP. |
LAWRENCE WEINSTEIN |
| K003093 |
11/27/2000 |
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K002262 |
11/28/2000 |
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K002047 |
11/22/2000 |
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K002608 |
11/16/2000 |
INVAC |
DUNCAN HYND ASSOCIATES, LTD. |
DIANA UPTON |
| K003473 |
11/28/2000 |
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM |
ELSCINTEC SYSTEMS LTD. |
ELLIOT MARSHALL |
| K002615 |
11/13/2000 |
SURGICAL SYSTEM WITH CRYOGUIDE |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K003497 |
11/30/2000 |
DISPOSABLE PRESSURE MONITOR |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
| K002778 |
11/22/2000 |
ENTERIC INJECTION CATHETER WITH IRRIGATION |
ENTERIC MEDICAL TECHNOLOGIES, INC. |
JILL M VISOR |
| K001177 |
11/13/2000 |
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI |
ENTERIC PRODUCTS, INC. |
JEFFREY PEACOCK |
| K001788 |
11/03/2000 |
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 |
ERECORDS ENTERPRISES |
ED GOSS |
| K002398 |
11/03/2000 |
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING |
ETHICON ENDO-SURGERY, INC. |
EDWIN O BILLIPS |
| K003070 |
11/07/2000 |
ETHIBOND EXCEL VALVE LOOP SUTURE |
ETHICON, INC. |
GREGORY R JONES |
| K002672 |
11/22/2000 |
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH |
ETHICON, INC. |
KAREN LESSIG |
| K003133 |
11/07/2000 |
MULTIPLE-VINYL EXAM GLOVE, POWDERED |
EXCELLENCE ENT. CO., LTD. |
JANNA P TUCKER |
| K003408 |
11/17/2000 |
CT CORD IQ OPTION 1.0 |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K002089 |
11/21/2000 |
ROSETTA-LT/ROSETTA-RX |
GENERAL DEVICES |
MICHAEL SMITH |
| K001440 |
11/13/2000 |
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
MARY E GRAY |
| K003063 |
11/22/2000 |
GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION |
GIMBEL GLOVE CO., LLC. |
GORDON P PARDY |
| K002662 |
11/02/2000 |
HARDYDISK CLINDAMYCIN, 2MCG |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR |
| K002593 |
11/29/2000 |
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM |
HARTALEGA SDN BHD |
NURUL A KONG |
| K003359 |
11/27/2000 |
COLOSCREEN-ES |
HELENA LABORATORIES |
PAT FRANKS |
| K003335 |
11/17/2000 |
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER |
HILL-ROM AIR-SHIELDS |
LARRY W KRASLEY |
| K002692 |
11/17/2000 |
DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A |
HMI INDUSTRIES, INC. |
JACQUELINE A PURCELL |
| K003413 |
11/24/2000 |
ALUMINA V40 HEAD |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K002552 |
11/13/2000 |
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K003391 |
11/28/2000 |
OSTEONICS ALUMINA C-TAPER HEAD |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K003379 |
11/30/2000 |
V-40/C-TAPER ADAPTER SLEEVE |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K001213 |
11/03/2000 |
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 |
HUDSON RESPIRATORY CARE, INC. |
DANA HOUGHTON |
| K003471 |
11/20/2000 |
MAGNA TEK ESU-400 |
HUTTINGER MEDIZINTECHNIK GMBH & CO KG |
BERNHARD HUG |
| K002764 |
11/24/2000 |
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR |
HYDROCISION, INC. |
DEBBIE IAMPIETRO |
| K001948 |
11/01/2000 |
CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM |
HYPERTENSION DIAGNOSTICS, INC. |
CHARLES F CHESNEY |
| K002886 |
11/24/2000 |
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) |
IMPLANTECH ASSOCIATES, INC. |
EDWARD LEICHT |
| K003181 |
11/07/2000 |
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ |
IMPLEX CORP. |
JOHN SCHALAGO |
| K000023 |
11/06/2000 |
FRIENDLY LIGHT ER:YAG PULSED LASER |
INNOTECH USA, INC. |
THOMAS BECZE |
| K002600 |
11/15/2000 |
LITWIN CRUICATE ANCHOR |
INSTRUMENT MAKAR, INC. |
LANNY L JOHNSON |
| K002472 |
11/29/2000 |
DELTA 32 AND DELTA 32 TACT |
INSTRUMENTARIUM IMAGING, INC. |
TOMMI JOKINIEMI |
| K002392 |
11/02/2000 |
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V |
INTEGRA NEUROCARE LLC. |
NANCY MATHEWSON |
| K002765 |
11/24/2000 |
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE |
INTEGRA NEUROSCIENCES |
NANCY MATHEWSON |
| K001521 |
11/27/2000 |
SOFTSENS |
INTEGRATED BIOSENSING TECHNOLOGIES |
RONALD LUICH |
| K003204 |
11/07/2000 |
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT |
INTRACEL CORP. |
SHANE WARD |
| K003373 |
11/28/2000 |
PROCAD ADD-ON |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K002872 |
11/02/2000 |
R&D PROJECT DW271#11A |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K002598 |
11/22/2000 |
EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING |
J. H. EMERSON CO. |
GEORGE EMERSON |
| K002640 |
11/08/2000 |
FREEDOM AUTOMATIC FILM PROCESSOR |
J. MORITA USA, INC. |
VICTOR MAZZANTI |
| K002993 |
11/16/2000 |
HERACERAM |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K003011 |
11/28/2000 |
SELF ETCH BONDING PRIMER |
JENERIC/PENTRON, INC. |
ANUMARIE TENERO |
| K002904 |
11/06/2000 |
WILLI GELLER CREATION AND LF PORCELAIN |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K003197 |
11/22/2000 |
VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW |
KAOHSIUNG BROTHERS PRODUCTS CORP. |
STONE CHEN |
| K002924 |
11/03/2000 |
3D ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNEN |
| K000806 |
11/30/2000 |
KARL STORZ HYSTEROMAT II |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K002704 |
11/03/2000 |
KSEA MINIATURE NEUROENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K002806 |
11/21/2000 |
K-DEFIB/PACE, MODEL KDP-60A |
KATECHO, INC. |
WARREN R WALTERS |
| K000870 |
11/07/2000 |
KM-10 TENS ELECTRODE |
KATECHO, INC. |
WARREN R WALTERS |
| K002708 |
11/28/2000 |
KAVO CORUND HANDPIECE 2013 |
KAVO AMERICA |
JOHN WESTERMEIER |
| K002805 |
11/09/2000 |
KENDRO HERACELL CO2 INCUBATOR |
KENDRO LABORATORY PRODUCTS, L.P. |
SUSAN D GOLDSTEIN-FALK |
| K002859 |
11/16/2000 |
SSW-STERILE SOLUTION WARMER |
KMI KOLSTER METHODS, INC. |
ALWIN H KOLSTER |
| K002390 |
11/02/2000 |
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H |
LSI INTL., INC. |
JAMES C LANES |
| K003315 |
11/08/2000 |
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA |
MALLINCKRODT, INC. |
JAMES C KEEVEN |
| K003167 |
11/08/2000 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K003244 |
11/08/2000 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K002781 |
11/29/2000 |
MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS |
MEDICAL CABLES, INC. |
CHRISTOPHER FONTANA |
| K003525 |
11/22/2000 |
VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
GARY ALLSEBROOK |
| K003353 |
11/22/2000 |
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K002023 |
11/13/2000 |
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 |
MEDMIRA LABORATORIES, INC. |
TODD BISHOP |
| K002363 |
11/01/2000 |
MEDOVATIONS ESOPHAGEAL DILATOR |
MEDOVATIONS, INC. |
MICHAEL J BROWN |
| K001663 |
11/16/2000 |
FRONT-LOAD POLYPROPYLENE SYRINGE |
MEDRAD, INC. |
FRANK W PELC III |
| K002572 |
11/16/2000 |
MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 |
MEDTRONIC PS MEDICAL |
JANET MCAULEY |
| K002103 |
11/02/2000 |
SIMPLICITY SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K002931 |
11/24/2000 |
METRX SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K001714 |
11/03/2000 |
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 |
MERCURY MEDICAL |
RON RUPENSKI |
| K001347 |
11/03/2000 |
MERIDIAN-II AND MERDIAN-PLUS |
MERIDIAN CO., LTD. |
SOO-RANG LEE |
| K002812 |
11/08/2000 |
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE |
MICHAEL REYNARD, M.D. |
MICHAEL REYNARD |
| K001544 |
11/17/2000 |
VAGINAL APPLICATOR SHIELDED |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K003308 |
11/14/2000 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K002059 |
11/13/2000 |
AMT SPINAL SYSTEM |
MICRON PRECISION ENGINEERING, INC. |
FRANK E BAILY |
| K002864 |
11/21/2000 |
MODEL 6600GE-64: TRAMA NECK ARRAY |
MIDWEST R.F. LLC. |
RALPH S HASHOIAN |
| K002860 |
11/22/2000 |
MODEL 6900GE-64: C-SPINE ARRAY |
MIDWEST R.F. LLC. |
RALPH S HASHOIAN |
| K002774 |
11/16/2000 |
HRH-63 HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K003340 |
11/08/2000 |
OBC-149 BREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K003331 |
11/08/2000 |
QWH-149 WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K003349 |
11/13/2000 |
ALLON 2001 MODIFIED |
MTRE ADVANCED TECHNOLOGY LTD. |
PAUL DRYDEN |
| K003287 |
11/06/2000 |
MODEL K7 EVALUATION DEVICE |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
| K003302 |
11/22/2000 |
IM-5A INJECTOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K003303 |
11/22/2000 |
IM-5B MICROINJECTOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K003304 |
11/22/2000 |
IM-6 MICROINJECTOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K003300 |
11/22/2000 |
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K003298 |
11/21/2000 |
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K001455 |
11/02/2000 |
ACCUWELL TSH, MODEL KAW-TSH-960 |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K001564 |
11/24/2000 |
SCAN LT40 (40 CHANNELS) |
NEURO SCAN LABS |
DAVID B JONES |
| K001692 |
11/24/2000 |
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 |
NEUROSOFT, INC. |
DAVID B JONES |
| K002766 |
11/30/2000 |
NICOLET VASOGUARD |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
| K002623 |
11/20/2000 |
PURESPERM 40 AND PURESPERM 80 |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K002630 |
11/21/2000 |
PURESPERM WASH |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K001433 |
11/07/2000 |
CNS-9300 SERIES CENTRAL STATION |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K002473 |
11/08/2000 |
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K003444 |
11/21/2000 |
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K002813 |
11/21/2000 |
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
RICHARD D BLISS |
| K002475 |
11/09/2000 |
REPLACE TPS COATED IMPLANTS |
NOBEL BIOCARE UAS INC |
DON KENNARD |
| K000404 |
11/22/2000 |
PC ECG 1200 |
NORAV MEDICAL LTD. |
STEVE SPRINGROSE |
| K002724 |
11/17/2000 |
NUMALINK |
NUMA, INC. |
LARRY SMITH |
| K003114 |
11/01/2000 |
NUMED TYSHAK AND Z-MED PTV CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
| K003052 |
11/01/2000 |
NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
| K002677 |
11/13/2000 |
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
NUVASIVE, INC. |
R. STEPHEN REITZLER |
| K002966 |
11/08/2000 |
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR |
OCU-EASE OPTICAL PRODUCTS, INC. |
CHARLES R VERNETTE |
| K002703 |
11/21/2000 |
O-PERM 30 |
OPTICAL POLYMER RESEARCH, INC. |
WERNER P SCHUMAN |
| K002620 |
11/16/2000 |
SURESMILE SYSTEM |
ORA METRIX, INC. |
NANCY BUTCHER |
| K002010 |
11/29/2000 |
STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K003256 |
11/08/2000 |
PCCR DIGITAL IMAGING DEVICE |
OREX COMPUTED RADIOGRAPHY LTD |
ROSINA ROBINSON |
| K003112 |
11/02/2000 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
SUSAN WERNER |
| K003028 |
11/24/2000 |
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC |
OSTEOGENICS BIOMEDICAL, INC. |
CHAD BARTEE |
| K003384 |
11/24/2000 |
VERSALINK TITANIUM ROD-TO-ROD COUPLERS |
OSTEOTECH, INC. |
KIM THURMAN |
| K002787 |
11/29/2000 |
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 |
PALCO LABS, INC. |
RICHELLA GOO |
| K002649 |
11/21/2000 |
ARAMIS DERMATOLOGICAL LASER |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K002024 |
11/22/2000 |
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA |
PANBIO, INC. |
DAVID C BISHOP |
| K002486 |
11/09/2000 |
PRECIMED TRAUMA SYSTEM |
PATRICK BERDOZ |
PATRICK BERDOZ |
| K003414 |
11/27/2000 |
VARELISA TG (THYROGLOBULIN) ANTIBODIES, |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K002476 |
11/09/2000 |
LUMBOPERITONEAL SHUNT SYSTEM |
PHOENIX BIOMEDICAL CORP. |
COURTNEY SMITH |
| K002357 |
11/09/2000 |
100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS |
PIE MEDICAL |
COLLEEN J HITTLE |
| K002629 |
11/20/2000 |
SILMAX CONTOUR CARVING BLOCK IMPLANT |
PILLAR SURGICAL, INC. |
ROB FRITZENKOTTER |
| K002633 |
11/21/2000 |
SILMAX PECTORAL IMPLANT |
PILLAR SURGICAL, INC. |
ROB FRITZENKOTTER |
| K002582 |
11/03/2000 |
PILLING E-FRAZIER BIPOLAR SUCTION TUBE |
PILLING |
ELIZABETH LAZARO |
| K002571 |
11/16/2000 |
MULITPLE MALE LATX CONDOM |
PLEASURE LATEX PRODUCTS SDN. BHD. |
KOI-YONG LIM |
| K002199 |
11/20/2000 |
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
RON JAMISON |
| K002214 |
11/21/2000 |
SINUSCOPE AND BACCESSORIES |
POLLUX ENDOSCOPY, INC. |
PRECIOUS J RESCH |
| K002586 |
11/17/2000 |
MEDPOR PTERIONAL SURGICAL IMPLANT |
POREX SURGICAL PRODUCTS GROUP |
HOWARD MERCER |
| K002707 |
11/08/2000 |
PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING |
PRECISION VASCULAR SYSTEMS, INC. |
JOHN R RAGAZZO |
| K002725 |
11/21/2000 |
MICROPAQ, MODELS 402 AND 404 |
PROTOCOL SYSTEMS, INC. |
DON M ABBEY |
| K002752 |
11/20/2000 |
BAYONET FORCEPS BIPOLAR IRRIGATING |
Q2 MEDICAL |
ERIC MILLS |
| K001278 |
11/29/2000 |
SENSAIRE DIAGNOSTIC SPIROMETER |
QRS DIAGNOSTIC, LLC. |
JILL R KRALL |
| K003096 |
11/30/2000 |
FASTPACK CALIBRATORS |
Qualigen, Inc. |
DOROTHY DEINZER |
| K003095 |
11/29/2000 |
FASTPACK CONTROL |
Qualigen, Inc. |
DOROTHY DEINZER |
| K003069 |
11/27/2000 |
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM |
QUEST INTL., INC. |
ROBERT A CORT |
| K003208 |
11/07/2000 |
R & D 3K RETIC |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K003236 |
11/02/2000 |
RETINADX |
REGULATORY ASSOCIATES, INC. |
Kevin Walls |
| K003142 |
11/22/2000 |
MICROMANIPULATOR |
RESEARCH INSTRUMENTS LTD. |
BEN MURDOCK |
| K003233 |
11/03/2000 |
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K003261 |
11/16/2000 |
CREATININE PLUS |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K002520 |
11/13/2000 |
ROVERS SPATULA |
ROVERS MEDICAL DEVICES B.V. |
TODD M GATES |
| K002502 |
11/08/2000 |
CERAM-PRIME |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K002098 |
11/24/2000 |
SALUMEDICA NERVE CUFF |
SALUMEDICA, L.L.C. |
DAVID N KU |
| K002062 |
11/09/2000 |
SAMSUNG 10DR IMPLANT SYSTEM |
SAMSUNG SDS CO., LTD |
CARL ALLETTO |
| K001563 |
11/22/2000 |
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET |
SCION CARDIOVASCULAR, INC. |
DAVID B JONES |
| K003046 |
11/24/2000 |
IMAGE VASCULAR LASER |
SCITON, INC. |
PETER ALLEN |
| K003282 |
11/01/2000 |
FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H |
SEIN ELECTRONICS CO., LTD. |
WON KY KIM |
| K003321 |
11/22/2000 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K002818 |
11/29/2000 |
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
WILLIAM HARRIS |
| K002819 |
11/29/2000 |
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE |
SIAM SEMPERMED CORP. LTD. |
WILLIAM HARRIS |
| K003179 |
11/09/2000 |
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K002463 |
11/08/2000 |
STELLAR |
SKYTRON, DIV. THE KMW GROUP, INC. |
KARI OGREEN |
| K000253 |
11/16/2000 |
SILENT NIGHT V |
SLEEP SOLUTIONS, INC. |
CAROLE M SYKES |
| K002740 |
11/30/2000 |
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K002991 |
11/28/2000 |
ZAP DUAL CURING LIGHT |
SOFT-CORE TEXAS, INC. |
ROY MARTIN |
| K003399 |
11/16/2000 |
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM |
SONOSITE,INC. |
MICHAEL A HOFFMAN |
| K002521 |
11/13/2000 |
SPARTAN MTS |
SPARTAN MARKETING GROUP |
ALDO E EAGLE |
| K003079 |
11/21/2000 |
SPECIALTY TINT SOFT CONTACT LENS |
SPECIALTY TINT |
ROBERT BREECE |
| K003087 |
11/07/2000 |
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION |
SPORICIDIN INTL. |
HAROLD E PLANK |
| K002834 |
11/29/2000 |
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR |
SRS MEDICAL SYSTEMS, INC. |
LEE BRODY |
| K002861 |
11/29/2000 |
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K003007 |
11/17/2000 |
GALAXY |
STERNGOLD |
SUSAN L SPEAR |
| K002374 |
11/01/2000 |
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT |
STRAUMANN USA |
LINDA JALBERT |
| K002619 |
11/16/2000 |
NEWGEN SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
| K002843 |
11/15/2000 |
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K002575 |
11/15/2000 |
INTER-OP DURASUL ACETABULAR INSERTS (4MM) |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K002786 |
11/17/2000 |
BIOSENSORS CENTRAL VENOUS CATHETER KITS |
SUNSCOPE INTL., INC. |
JORGE HAIDER |
| K002916 |
11/28/2000 |
SURGI-VISION PROSTATE COIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K002605 |
11/20/2000 |
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW |
SYNTHES (USA) |
BONNIE J SMITH |
| K002935 |
11/16/2000 |
SYNTHES 1.5MM TI BROW LIFT SCREW |
SYNTHES (USA) |
THOMAS M MAGUIRE |
| K002362 |
11/01/2000 |
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) |
SYNTHES (USA) |
BONNIE J SMITH |
| K001841 |
11/15/2000 |
35/CD CINECONVERTER |
TAGARNO A/S |
MAX JENS JENSEN |
| K003306 |
11/22/2000 |
C. DIFFICILE TOX A/B II |
TECHLAB, INC. |
DAVID M LYERLY |
| K003424 |
11/21/2000 |
PINNACLE R/O II OR RADIFOCUS INTRODUCER II |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
| K002840 |
11/17/2000 |
MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM |
THE PHANTOM LABORATORY, INC. |
JOSHUA R LEVY |
| K002720 |
11/09/2000 |
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
| K002680 |
11/13/2000 |
TISSUELINK MONOPOLAR FLOATING BALL' |
TISSUELINK MEDICAL, INC. |
ROBERTA THOMPSON |
| K001947 |
11/22/2000 |
T.I.M.S., VERSION 2.00 |
TOTAL MEDICAL INFORMATION MANAGEMENT SYSTEMS, INC. |
DON BEAVERS |
| K002816 |
11/22/2000 |
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K001676 |
11/02/2000 |
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A |
TRIMEDYNE, INC. |
SUSAN H GAMBLE |
| K001525 |
11/29/2000 |
CAPTIA SYPHILIS-G ELISA TEST SYSTEM |
TRINITY BIOTECH, PLC |
WAYNE KVETKOSKY |
| K002990 |
11/06/2000 |
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 |
VASCULAR TECHNOLOGY INCORPORATED |
DAVID L REGAN |
| K002780 |
11/17/2000 |
VIATRONIX VISUALIZATION SYSTEM (VVS) |
VIATRONIX, INC. |
SUSAN D GOLDSTEIN-FALK |
| K992529 |
11/17/2000 |
TISSUE SPECTROSCOPE |
VITAL MEDICAL LTD. |
BRUCE F MACKLER |
| K003153 |
11/15/2000 |
SOLOBOND PLUS |
VOCO GMBH |
EVAN DICK |
| K002184 |
11/24/2000 |
COD COMPRESSION OSTEOTOMY DEVICE |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K002714 |
11/28/2000 |
WARTNER WART REMOVAL SYSTEM |
WARTNER MEDICAL PRODUCTS |
JUDY MAGNER |
| K002530 |
11/14/2000 |
WELCH ALLYN SPOT CHECK DEVICE |
WELCH ALLYN, INC. |
JOSEPH D BUCHANAN |
| K993852 |
11/29/2000 |
FIRST CHECK HOME DRUG TEST PANEL 4 |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
| K002683 |
11/22/2000 |
WMT ULTRA-FIT MODULAR SHOULDER SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K001613 |
11/22/2000 |
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WHA CHOW |
| K002064 |
11/28/2000 |
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K003019 |
11/03/2000 |
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K003132 |
11/17/2000 |
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
| K003309 |
11/22/2000 |
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
| K003307 |
11/22/2000 |
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
| K002961 |
11/21/2000 |
MINITUB MULTI-PURPOSE CASSETTES |
ZANDER MEDICAL SUPPLIES, INC. |
FRIEDEL MW ZANDER |
| K003184 |
11/20/2000 |
RS BIOTECH GALAXY 'R' CO2 INCUBATOR |
ZANDER MEDICAL SUPPLIES, INC. |
FRIEDEL MW ZANDER |
| K002687 |
11/09/2000 |
ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 |
ZYNERGY CARDIOVASCULAR, INC. |
JING ZHANG |
