FDA 510(k) Applications Received During March, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K020946 03/25/2002 ADPER PROMPT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K020768 03/07/2002 3T VESSEL CANNULAS 3T MEDICAL SYSTEMS, LLC. ROBERT P EATON
K020748 03/07/2002 ETEST ERTAPENEM AB BIODISK ANNE BOLMSTROM
K020866 03/18/2002 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM ABBOTT DIABETES CARE INC. DONNA K TEMPLEMAN
K020984 03/18/2002 ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS ACCESS CARDIOSYSTEMS, INC. DAVID BARASH
K020892 03/19/2002 ACIST GENTOO CONTRAST INJECTION SYSTEM ACIST MEDICAL SYSTEMS CARL M BEAURLINE
K021015 03/29/2002 ACIST PLUS 4 ANGIOGRAPHIC CATHETER ACIST MEDICAL SYSTEMS CARL M BEAURLINE
K020951 03/25/2002 H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 ACKRAD LABORATORIES RICHARD HETTENBACH
K020954 03/25/2002 H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY ACKRAD LABORATORIES RICHARD HETTENBACH
K020771 03/08/2002 ACON ONE STEP DRUG SCREEN TEST CARD ACON LABORATORIES, INC. EDWARD TUNG
K021008 03/28/2002 ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K020728 03/06/2002 MIETHKE SHUNT SYSTEM AESCULAP, INC. JOYCE KILROY
K020818 03/13/2002 POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K020668 03/01/2002 ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 ALOKA CO., LTD. KELVIN BURROUGHS
K020663 03/01/2002 MODIFICATION TO SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. MARK MCINTYRE
K020865 03/18/2002 ONLINE POWDER FREE, LATEX EXAMINATION GLOVES APL PRODUCTS SDN. BHD. LEE SON HONG
K020838 03/14/2002 ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) AR ALLIANCE HEALTHCARE SDN. BHD. CHAU CHOON CHUAN
K020832 03/14/2002 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K020683 03/04/2002 ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 ATI MEDICAL, INC. MICHAEL WIENHOLT
K020919 03/21/2002 ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 ATRICURE, INC. MARK L FRIEDMAN
K020767 03/08/2002 ADVANTA SST BIFURCATED GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K020738 03/06/2002 AVITA BF1 (VITALIO) BODY FAT ANALYZER AVITA CORPORATION JENNIFER REICH
K020687 03/04/2002 DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300 AXIS-SHIELD DIAGNOSTICS, LTD. EILEEN MCCAFFERTY
K020785 03/11/2002 INTROCAN SAFETY IV CATHETER B. BRAUN MEDICAL, INC. AMY S KRALL
K021033 03/29/2002 STIMUPLEX-DIG-RC NERVE STIMULATOR B. BRAUN MEDICAL, INC. SHERI L MUSGNUNG
K020927 03/21/2002 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB DEBRA L. B KETCHUM
K020802 03/12/2002 RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION BAUSCH & LOMB INCORPORATED PAUL G STAPLETON
K020666 03/01/2002 DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML BAXTER HEALTHCARE CORP. ARLENE VIDOR
K020806 03/12/2002 ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY BAYER CORP. THOMAS F FLYNN
K020828 03/14/2002 CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER CORP. KENNETH T EDDS
K020792 03/11/2002 ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020807 03/12/2002 AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020794 03/11/2002 SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K020739 03/06/2002 BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR BCI, INC. DONALD J ALEXANDER
K020842 03/15/2002 ERTAPENEM 10UG BBL SENSI-DISC BECTON DICKINSON & CO. MICHELLE BANDY
K020834 03/14/2002 BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LASLIE WOOD
K020921 03/21/2002 NO-POKES NEEDLE SAFETY DEVICE BEMIS MFG. CO. JOHN B HOWELL
K020878 03/18/2002 LYPHOCHEK HEMOSTASIS, MODELS 798, 799 BIO-RAD MARIA ZEBALLOS
K020817 03/13/2002 LIQUICHEK URINE CHEMISTRY CONTROL BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K020835 03/14/2002 CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 BIOLITEC, INC. JONATHAN S KAHAN
K020712 03/05/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K020813 03/13/2002 BACT/ALERT FA CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020815 03/13/2002 BACT/ALERT FN CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020923 03/21/2002 BACT/ALERT PF CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020931 03/22/2002 BACT/ALERT SA CULTURE BOTTLE BIOMERIEUX, INC. RON SANYAL
K020810 03/13/2002 VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 BIOMERIEUX, INC. SANDRA PERREAND
K020962 03/25/2002 G4 SLEEVED NAIL BIOMET MANUFACTURING, INC. TRACY J BICKEL
K020905 03/20/2002 NBX - NON-BRIDGING EXTERNAL FIXATOR BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K020963 03/25/2002 TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K020819 03/13/2002 DISTAL RADIUS PLATING SYSTEM BIOMET, INC. MARY VERSTYNEN
K020970 03/26/2002 MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) BIOMET, INC. TRACY J BICKEL
K020761 03/07/2002 POWER TEK II BIOMET, INC. PATRICIA S BERES
K020863 03/18/2002 CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. WILLIAM WELCH
K020710 03/05/2002 BIOTEST HEMOGLOBIN MEASURING SYSTEM BIOTEST MEDIZINTECHNIK GMBH MARK LICATA
K021029 03/29/2002 ABP-2000 G-3 BIOTRAC, INC. JAIME GUTTMAN
K020821 03/13/2002 SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117 BIOTRONIK, INC. Jon Brumbaugh
K020746 03/07/2002 BIRD TBIRD VELA VENTILATOR BIRD PRODUCTS CORP. TOM GUTIERREZ
K020730 03/06/2002 ORION NASAL CPAP SYSTEM BIRD PRODUCTS CORP. TOM GUITERREZ
K020674 03/01/2002 BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K020765 03/08/2002 MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K020824 03/14/2002 SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K020833 03/14/2002 BOYD DELIVERY UNIT BOYD INDUSTRIES, INC. BRUCE LIVINGSTON
K020860 03/18/2002 M3 (MICRO-MULTILEAF COLLIMATOR) BRAINLAB AG STEFAN VILSMEIER
K020988 03/27/2002 PAIN CARE 4200 BREG, INC. KATHLEEN BARBER
K020682 03/04/2002 BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. CAROL VIERLING
K020851 03/15/2002 TDP HEAT LAMP OR INFRARED HEATING LAMP, MODELS CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D C&H INTERNATIONAL YUANHUI LUO
K020702 03/04/2002 O'REGAN DISPOSABLE ANOSCOPE CANADIAN THEATRE PRODUCTS LTD. ANN-MARIE O'KEEFE
K020958 03/25/2002 CANDELA CBEAM PULSED DYE LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K020825 03/14/2002 KING OF HEARTS EXPRESS + AF MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALDEN KAY
K020735 03/06/2002 SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES CATHAY INTERNATIONAL, LTD. ANNE JEN
K020803 03/12/2002 CEFAR MEDICAL AB CEFAR PRIMO CEFAR MEDICAL AB CONSTANCE G BUNDY
K020695 03/04/2002 QAB2A IGG ELISA KIT CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K020694 03/04/2002 QAB2A IGM ELISA KIT CHESHIRE DIAGNOSTICS LTD. NEIL B STRINGER
K020667 03/01/2002 CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. ELIZABETH DOLAN
K020732 03/06/2002 SS MATRIX COOK BIOTECH, INC. MARK BLEYER
K020809 03/13/2002 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT CORDIS CORP. DONNA MARSHALL
K020680 03/04/2002 PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K020776 03/11/2002 MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS CORONET GROUP NORTH AMERICA, LLC. THOMAS E FERARI
K020745 03/07/2002 COSMED MICROQUARK COSMED S.R.L. ROBERT SCHIFF
K020920 03/21/2002 COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE COZART BIOSCIENCE LTD. ROBERTO LIDDI
K020723 03/06/2002 DIMENSION ALDL CALIBRATOR, MODEL DC131 DADE BEHRING, INC. RICHARD M VAUGHT
K020724 03/06/2002 DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 DADE BEHRING, INC. RICHARD M VAUGHT
K020980 03/26/2002 DIMENSION TPSA CALIBRATOR, MODEL #RC459 DADE BEHRING, INC. GEORGE M PLUMMER
K020692 03/04/2002 EMIT 2000 VANCOMYCIN ASSAY DADE BEHRING, INC. DONNA A WOLF
K020845 03/15/2002 EMIT 2000 VANCOMYCIN CALIBRATORS DADE BEHRING, INC. DONNA A WOLF
K020820 03/13/2002 MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME DADE BEHRING, INC. CYNTHIA VAN DUKER
K020822 03/13/2002 MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K020979 03/26/2002 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 DADE BEHRING, INC. REBECCA S AYASH
K021018 03/29/2002 MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020691 03/04/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020686 03/04/2002 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020937 03/22/2002 MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020938 03/22/2002 MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020939 03/22/2002 MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K020760 03/07/2002 STARFLOW HV DANVILLE MATERIALS, INC. CRAIG R BRUNS
K020655 03/01/2002 DELTEC INSULIN INFUSION PUMP AND ACCESSORIES DELTEC, INC. LISA STONE
K020893 03/19/2002 NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE DENNIS R. BAILEY, DDS DENNIS R BAILEY
K020697 03/04/2002 DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. MARIO RUSSO
K020753 03/07/2002 DEROYAL SURGICAL, UMBILICUP DEROYAL AUDREY DANIELS
K020816 03/13/2002 IRON-PC-SL ASSAY MODEL # 151-10, 151-26 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K020945 03/25/2002 AXSYM INTACT PTH, MODEL 2G06 DIAGNOSTIC SYSTEMS LABORATORIES, INC. CARROLL POTTS
K020997 03/28/2002 APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K020903 03/20/2002 DOCXS B SERIES ELECTRODES DOCXS, LLC RICHARD RIZZOLO
K020924 03/21/2002 CUSTODIOL HTK SOLUTION DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K020726 03/06/2002 DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE DUKAL CORP. PATRICK J LAMB
K020887 03/18/2002 EBI AIS SPINE SYSTEM EBI, L.P. FREDERIC TESTA
K020681 03/04/2002 EBI OMEGA21 SPINAL FIXATION SYSTEM EBI, L.P. PATRICIA FLOOD
K021031 03/29/2002 EBI XFIX RAIL SYSTEM EBI, L.P. MICHAEL T TAGGART
K020918 03/21/2002 ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE ECI MEDICAL TECHNOLOGIES, INC. SHIRANTHA SAMARAPPULI
K020864 03/18/2002 EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 EDWARDS LIFESCIENCES, LLC. SUSAN REYNOLDS
K020995 03/28/2002 EFILM WORKSTATION WITH MODULES EFILM MEDICAL, INC. JOSEPH A THOMAS
K020693 03/04/2002 AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 EMBOL-X, INC. EDWIN LEE
K020741 03/06/2002 UNICONDYLAR KNEE ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K020925 03/21/2002 CARBODISSECTING ENDOSCOPE ENDO SURGICAL DEVICES, INC. DEBBIE IAMPIETRO
K021010 03/29/2002 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE ENDOCARE, INC. EBEN GORDON
K020974 03/26/2002 BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP. MICHAEL W ALLEN
K020926 03/21/2002 EXTENSION SET, MODELS 1911-512 EPIMED INTERNATIONAL, INC. CHRISTOPHER B LAKE
K020779 03/11/2002 PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS ETHICON ENDO-SURGERY, INC. DOUG KENTZ
K020750 03/07/2002 DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K020749 03/07/2002 DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K020684 03/04/2002 FINESUN EMS STIMULATOR FINESUN WORLDWIDE INTL. CO., LTD. CHI-CHU WU CHEN
K021030 03/29/2002 TITANIUM CANNULATED INTERFERENCE SCREW FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K020933 03/22/2002 GARAVENTA SUPER-TRAC TRE-52 GARAVENTA ACCESSIBILITY NORM COOPER
K021016 03/29/2002 AMX-4 PLUS MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K020796 03/12/2002 CARD IQ ANALYSIS II GE MEDICAL SYSTEMS LARRY A KROGER
K020929 03/22/2002 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE MEDICAL SYSTEMS
K020789 03/11/2002 GE VIVID 3 EXPERT; GE VIVID 3 PRO GENERAL ELECTRIC CO. ALLEN SCHUH
K020661 03/01/2002 UNITY IS PATIENT VIEWER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K021019 03/29/2002 COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE GENZYME CORP. MARY GRAY
K021028 03/29/2002 MODEL GT980201 ELECTRONIC THERMOMETER GLOBAL TREASURE LTD. BEN MA
K020891 03/19/2002 NAKAO SNARE II AND NAKAO SNARE III GRANIT MEDICAL INNOVATIONS NAOMI L NAKAO
K020701 03/04/2002 SYNCRUS INTERNAL CARDIOVERSION SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY DEBBIE COGAN
K020778 03/11/2002 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 GYRUS ENT L.L.C. JEFFERY W COBB
K020987 03/27/2002 BMN I TYPE MARROW ASPIRATION NEEDLE H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K020759 03/07/2002 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT HANS RUDOLPH, INC. KEVIN RUDOLPH
K020766 03/08/2002 HL168F HEALTH & LIFE CO., LTD. SUSAN CHEN
K020914 03/21/2002 ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 HELENA LABORATORIES PATRICIA FRANKS
K020935 03/22/2002 HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 HEMOCUE, INC. R.J. SLOMOFF
K020679 03/04/2002 INRATIO HEMOSENSE, INC. Judith Blunt
K020841 03/15/2002 AVON PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K020677 03/01/2002 GAMMA 3 LAG SCREW HOWMEDICA OSTEONICS CORP. WILLIAM J CYMBALUK
K020773 03/08/2002 LONG LENGTH GAMMA NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K020772 03/08/2002 OMEGA II SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021026 03/29/2002 S2 FEMORAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K021027 03/29/2002 S2 TIBIAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K020703 03/04/2002 SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING HOWMEDICA OSTEONICS CORP. MARGARET F CROWN
K020830 03/14/2002 SCORPIO INSET PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K020989 03/27/2002 SUPER EON PLUS FEMORAL STEMS HOWMEDICA OSTEONICS CORP. JENNIFER A DAUDELIN
K020688 03/04/2002 HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR HYDROCISION, INC. DEBBIE IAMPIETRO
K020660 03/01/2002 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO I-FLOW CORP. SHANE NOEHRE
K020862 03/18/2002 I-FLOW ELASTOMERIC PUMP I-FLOW CORP. SHANE NOEHRE
K020908 03/20/2002 HDM97 IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K020909 03/20/2002 HDM99 IBP INSTRUMENTS GMBH WERNER PFINGSTMANN
K020729 03/06/2002 NLITE SYSTEM,MODEL A00-1051 ICN PHOTONICS LTD. IAN MORTIMER
K020855 03/15/2002 IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT IGEL VISION CARE PTE LTD. DEBBIE MCINTIRE
K021025 03/29/2002 MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ IMPLEX CORP. ROBERT POGGIE
K021024 03/29/2002 HEMOSIL HIGH ABNORMAL CONTROL ASSAYED INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K021022 03/29/2002 HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K021023 03/29/2002 HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K020879 03/18/2002 IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001 INTEGRATED VASCULAR SYSTEMS, INC. SUSAN TURNER
K020798 03/12/2002 HEMOCHRON JR. SIGNATURE + INTERNATIONAL TECHNIDYNE CORP. JOHN CLAY
K020849 03/15/2002 APEX 800 LASER SYSTEM, MODEL APEX 800 IRIDEX CORP. JOHN D'ANGELO
K021017 03/29/2002 LEESPEC DISPOSABLE VAGINAL SPECULUM ITL CORPORATION, PTY LTD. WILLIAM L MOBBS
K020854 03/15/2002 MODIFICATION TO FOX PTA CATHETER JOMED AG CHRISTINA KICHULA
K020784 03/11/2002 JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS JOSTRA AG KATHLEEN JOHNSON
K020983 03/27/2002 JOSTRA SUCKERS, MODEL JS JOSTRA AG KATHLEEN JOHNSON
K020764 03/07/2002 NAVIPRO KINAMED, INC. VINEET K SARIN
K020781 03/11/2002 WET CHAMBER KINETIC CONCEPTS, INC. JUITH A HARBOUR
K020763 03/07/2002 COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) Lin-Zhi International, Inc. CHIU CHIN CHANG
K020769 03/07/2002 SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. CHIU CHIN CHANG
K020839 03/15/2002 QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL LUMENIS, INC. ALAN L VOSS
K020993 03/27/2002 ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) MAGNA-LAB, INC. JOHN GEISEL
K020880 03/18/2002 MARKNEW PRODUCTS ACUPUNCTURE NEEDLES MARKNEW PRODUCTS GREG HOLLAND
K020971 03/26/2002 DCM 2.0 MDS NORDION AB E. S MARTELL
K021004 03/28/2002 VALVED PEELABLE INTRODUCER MEDAMICUS, INC. KARYL HASKELL
K020936 03/22/2002 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL MEDCOMP FLORENCE A CAIKOSKI
K020996 03/28/2002 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL MEDEFIL, INC. PRADEEP AGGARWAL
K020999 03/28/2002 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL MEDEFIL, INC. PRADEEP AGGARWAL
K020780 03/11/2002 TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP MEDEX, INC. BARBARA LAW
K020911 03/20/2002 MID LABS AUTONOMOUS VIT ENHANCER (AVE) MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. LINDA M UPTON
K020907 03/20/2002 NEUROLINE, SUBDERMAL NEEDLE ELECTRODES MEDICOTEST A/S EMALEE G MURPHY
K020787 03/11/2002 VERDICT-II PROPOXYPHENE MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K020709 03/05/2002 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K020986 03/27/2002 MASTERGRAFT RESORBABLE CERAMIC MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K020699 03/01/2002 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
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