FDA 510(k) Decisions During March, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K970013 03/13/1997 BIORIGID NAIL TIBIA AAP GMBH AND CO. BETRIEBS KG DIPL.-ING CHRISTIAN ABEL
K952558 03/19/1997 AARON VAC 2 AARON MEDICAL INDUSTRIES J. ROBERT SARON
K954301 03/24/1997 ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) ABBOTT LABORATORIES MARY SPIEWAK
K970527 03/03/1997 ABBOTT HCG SERUM CONTROLS ABBOTT LABORATORIES KAREN L GATES, M.S.
K965186 03/24/1997 AXSYM B12 ABBOTT LABORATORIES LAURA L GRANITZ
K961661 03/04/1997 OXIMETRIX 4 COMPUTER SYSTEM ABBOTT LABORATORIES DAVID GUZEK
K965190 03/19/1997 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE ACCUMED INTL., INC. CYNTHIA C KNAPP
K965239 03/28/1997 PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) ACCUTRON, INC. JIM MOORE
K970046 03/28/1997 UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) ACCUTRON, INC. JAMES R MOORE
K965046 03/14/1997 ISOLA TWISTER CONNECTOR ACROMED CORP. WILLIAM CHRISTIANSON
K970693 03/21/1997 ACRYDERM GEL WOUND DRESSING ACRYMED, INC. BRUCE GIBBINS
K965028 03/17/1997 ACUMED SUTURE WASHER ACUMED, INC. SHARI L JEFFERS
K961459 03/26/1997 LEVEL 10 HDI ADVANCED TECHNOLOGY LABORATORIES, INC. TERRANCE J SWEENEY
K964128 03/17/1997 MCL 29 DERMABLATE ERBIUM LASER SYSTEM AESCULAP-MEDITEC GMBH WILLIAM T KELLEY
K970541 03/28/1997 AESCULAP MODULAR MONOPOLAR ELECTRODES AESCULAP, INC. MARY ELLEN HOLDEN
K961676 03/28/1997 AIRCAST VENAFLOW SYSTEM (MODIFICATION) AIRCAST, INC. STEPHEN L KENNEY
K951944 03/28/1997 NASALFLAIR AIRWAYS LTD., INC. WAYNE W DISANZA
K965185 03/31/1997 ACRYPAK FOLDER ALCON LABORATORIES MARTIN A KAUFMAN
K970268 03/31/1997 ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY ALEXANDER MFG. CO. STACEY HIPPEN
K970815 03/27/1997 CONVERTORS IMPERVIOUS SHOE COVERS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K964474 03/11/1997 ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES ALLEGIANCE HEALTHCARE CORP. INGRID M HOOS
K964910 03/10/1997 AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS ALPHA-OMEGA SERVICES, INC. CARY HEDGER
K961269 03/10/1997 PULSEMASTER AMERICAN DENTAL TECHNOLOGIES, INC. MICHAEL YESSIK
K970279 03/18/1997 RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2) AMERICAN ELECTROMEDICS CORP. NOEL A WREN
K952910 03/19/1997 THE SWIRLER NEBULIZER AMICI, INC. MICHAEL BONO
K964745 03/18/1997 AMSINO URINARY DRAINAGE BAG AMSINO INTL., INC. RICHARD Y LI, PH.D.
K964890 03/06/1997 ANATOM 2000 ANALOGIC CORP. JAMES R LEVANI
K961892 03/07/1997 SPECKTIN-LA TEST SET ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K964522 03/21/1997 ELLIPSE 4 ANDROMEDA MEDIZINISCHE SYSTEME GMBH NORMAN F ESTRIN, PH.D. , RAC
K964698 03/03/1997 SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT ANDWIN SCIENTIFIC A. THOMAS DOYLE
K963887 03/31/1997 PT-PAC PORTABLE HEATING PAD ANTHONY A. CHIURCO LAWRENCE E LIBERTI
K970744 03/31/1997 STYLE EYES OPTICS ANTI-RAY, INC. PHILIP KAHN
K970788 03/27/1997 PNEUMO-MATIC INSUFFLATION NEEDLE APPLE MEDICAL CORP. ROBERT W SCHAEFER
K970762 03/28/1997 DUAL LUMEN EMBOLECTOMY CATHETER APPLIED MEDICAL RESOURCES HOWARD V ROWE
K963318 03/03/1997 LEGIONELLA IGG/IGM ELISA TEST SYSTEM ARMKEL, LLC. WILLIAM L BOTELER JR.
K964609 03/06/1997 ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE ARRAY MEDICAL, INC. PATRICIA E BONNESS
K963257 03/04/1997 PERIPHERALLY INSERTED MEDLINE CATHETER ARROW INTL., INC. THOMAS D NICKEL
K932221 03/19/1997 NEUROLOGICAL OR CRANI TRAYS (PACKS) ASSOCIATED MEDICAL PRODUCTS CO. SCOTT WEISS
K963293 03/28/1997 AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K970064 03/17/1997 AMICAS WEB/INTRANET IMAGE SERVER AUTOCYT GROUP, INC. ADRIAN GROPPER, M.D.
K964359 03/25/1997 AVANTA ORTHOPAEDICS TENDON SPACER AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K965146 03/10/1997 FLAT CLOSED WOUND DRAIN WITH TROCAR AXIOM MEDICAL, INC. RIDWAN HARDY
K970359 03/18/1997 COMBIPROT EMERGENCY ENFUSION DEVICE B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K955179 03/12/1997 CONTRAST MEDIA SET B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K962141 03/19/1997 VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K964021 03/27/1997 INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) BAXTER EDWARDS PAULA A TORRIANNI
K963203 03/25/1997 BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT BAXTER HEALTHCARE CORP. SCOTT BEGGINS
K964029 03/17/1997 EMERGENCY RELIEF KIT SYSTEM BAXTER HEALTHCARE CORP. MARYALICE SMITH
K964853 03/31/1997 INTRAVIA CONTAINER, EMPTY BAXTER HEALTHCARE CORP. MARY E SNYDER
K970737 03/28/1997 B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K963974 03/06/1997 IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K964257 03/24/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K964843 03/06/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K963976 03/19/1997 IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K965240 03/10/1997 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L BECKMAN INSTRUMENTS, INC. SHERI HALL
K965108 03/06/1997 SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT BECKMAN INSTRUMENTS, INC. KATHLEEN M JAKER
K970212 03/06/1997 LEVOFLOXACIN, 5MCG, SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS VIRGINIA C WEINKNECHT
K970385 03/10/1997 SPARFLOZACIN, 5 MCG, SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS VIRGINIA C WEINKNECHT
K964860 03/03/1997 MARK 20 AND MARK 25 HAND ENGINE CONTROLLER BELL INTL., INC. DEWEY BELL
K970340 03/26/1997 AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER BELLAB MARTIN ERIKSSON
K964528 03/07/1997 (LENSES) BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE TINT BENZ RESEARCH AND DEVELOPMENT CORP. WALLY STIRLING
K970313 03/11/1997 PREPOWDERED LATEX EXAMINATION GLOVE BESGLOVE HEALTHCARE SDN. BHD. LIM HO PENG
K970666 03/10/1997 LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL BIO-RAD ELIZABETH PLATT
K960072 03/06/1997 SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX BIOCHEM IMMUNOSYSTEMS (U.S.), INC. RICHARD KEEN
K964047 03/19/1997 CRYOSIL SILICONE GEL SHEETING BIODERMIS CORP. DENNIS A REPELLA
K960373 03/05/1997 BIOJECTOR 2000 MODEL 1B02000 BIOJECT, INC. MARK K NORTON
K970615 03/19/1997 PROMED 55-G SOFT DAILY WEAR CONTACT LENS BIOMED DEVICES CORP. MARTIN J DALSING
K961021 03/17/1997 KIRSCHNER KNEE MODIFIED BIOMET, INC. JOHN WAGGONER
K961782 03/28/1997 BIO-BINKI BIOMNI MEDICAL SYSTEMS, INC. LAVON L BENNETT
K970565 03/28/1997 MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) BIOPSYS MEDICAL, INC. MARK A COLE, PH.D.
K964871 03/03/1997 BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS BIOSEARCH MEDICAL PRODUCTS, INC. ROLAN SOUBRA
K963936 03/31/1997 ACCESSPOINT, MED E-MAIL, DICOM READER BIOSOUND, INC. WAYNE NETHERCUTT
K963262 03/28/1997 ARTOSCAN M BIOSOUND, INC. WAYNE NETHERCUTT
K964604 03/10/1997 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION BIOTRONIK, INC. JOSEPH J SCHWOEBEL, RAC
K970452 03/06/1997 ELECSYS CALCHECK CEA BOEHRINGER MANNHEIM CORP. Patricia M Klimley
K970459 03/06/1997 ELECSYS CALCHECK CEA BOEHRINGER MANNHEIM CORP. Patricia M Klimley
K970458 03/06/1997 ELECSYS CALCHECK PSA BOEHRINGER MANNHEIM CORP. Patricia M Klimley
K964841 03/24/1997 ELECSYS PROGESTERONE ASSAY BOEHRINGER MANNHEIM CORP. MARY KENING
K964889 03/18/1997 ELECSYS TESTOSTERONE ASSAY BOEHRINGER MANNHEIM CORP. YVETTE LLODY
K965085 03/19/1997 ENZYMUN-TEST PSA BOEHRINGER MANNHEIM CORP. LEEANN CHAMBERS, RAC
K970052 03/25/1997 EXTRACTORRX BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K965229 03/04/1997 IMAGER TORQUE CATHETER BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K964538 03/10/1997 R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM BOSTON SCIENTIFIC CORP. WANDA M CARPINELLA
K970053 03/28/1997 ULTRATOMERX BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K960840 03/28/1997 C.E. VASCULAR MACHINE C.E. DIAGNOSIS, INC. CARLOS A SELMONOSKY
K964066 03/06/1997 DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) C.R. BARD, INC. PEGGY KEIFFER
K965125 03/19/1997 DAKOTA SMITH, NICOLE MILLER SUNGLASSES CALIFORNIA DESIGN STUDIO, INC. BRIAN SEIGEL
K963079 03/03/1997 CANON TX-10 TONOMETER CANON U.S.A., INC. GLENN IMPAL
K960849 03/26/1997 MAGNO ALARM CARDIAC ASSIST DEVICES, INC. RASSOLL RASHIDI
K963688 03/28/1997 FOCUS PV BALLOON DILATATION CATHETER CARDIOVASCULAR DYNAMICS, INC. MICHAEL CROCKER
K961380 03/17/1997 CPC PROBE CARL ZEISS, INC. KENNETH M NICOLL
K964852 03/03/1997 RADIACARE ORAL WOUND RINSE CARRINGTON LABORATORIES, INC. DENNIS R SPARKMAN, PH.D.
K962370 03/31/1997 PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE CHALLENGE PRODUCTS, INC. RICHARD O WOOD
K964198 03/19/1997 CAHSE AORTIC ROOT CANNULA CHASE MEDICAL, INC. BERT DAVIS
K964199 03/19/1997 CHASE CORONARY SINUS PERFUSION CANNULA CHASE MEDICAL, INC. BERT DAVIS
K964195 03/19/1997 CHASE TWO STAGE VENOUS RETURN CATHETER CHASE MEDICAL, INC. BERT DAVIS
K970087 03/06/1997 CR PERFECT CHIMERA RESEARCH & CHEMICAL, INC. CHARLES A HAY, PH.D.
K970539 03/24/1997 CHIRON DIAGNOSTICS ACS:180TU P CHIRON DIAGNOSTICS CORP. William J Pignato
K962109 03/13/1997 SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL CLASSY LADY BY MEHL OF PUERTO RICO, INC. THOMAS BLAKE
K964690 03/21/1997 LIBERTY VALVE CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K965214 03/28/1997 COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) COEUR LABORATORIES, INC. James M Clinton
K952567 03/04/1997 AUTOSTATTMII ANTI-DSDNA COGENT DIAGNOTICS LTD. JIM WESTON
K971057 03/28/1997 COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM COGENT LIGHT TECHNOLOGIES, INC. RICHARD B DAVIES
K970489 03/19/1997 COMEG ENDOSCOPY GRASPING FORCEPS COMEG ENDOSCOPY PETER DUFFY
K955841 03/11/1997 SLEEP SYSTEM FOR CLINICS & RESEARCH COMPUMEDICS PTD LTD. STEVE REITZLER
K963507 03/19/1997 EXTRA TENS (RI-2500) NEO TENS (RI-2000E) COMTEK INTL., CORP. PING TSUNG HUAN
K964844 03/24/1997 CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS CONMED CORP. IRA D DUESLER, JR.
K963787 03/11/1997 EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM CONMED CORP. IRA D DUESLER, JR.
K965082 03/11/1997 SOOTHING WATER-FILLED TEETHER CONSOLIDATED STORES CORP. JOHANN COZART
K970125 03/04/1997 NOAH MONITORING ELECTRODE SYSTEM CONTOUR MEDICAL TECHNOLOGY, INC. JOSH TRANTUM
K970391 03/06/1997 QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES CONTOUR MEDICAL TECHNOLOGY, INC. R. KEITH FERRARI
K970041 03/19/1997 ASCEND BALLOON DAILATION CATHETER COOK UROLOGICAL, INC. TAMMY BACON
K965211 03/11/1997 VISTA BRITE TIP CATHETERS CORDIS CORP. KATHERINE TREVISOL
K965181 03/21/1997 CES INFUSION CATHETER CORDIS NEUROVASCULAR, INC. JODI LYNN FRASIER
K965174 03/21/1997 TRUFILL PVA PARTICLES CORDIS NEUROVASCULAR, INC. JODI LYNN FRASIER
K965019 03/25/1997 THE C-FIT FEMORAL HIP SYSTEM CORIN U.S.A. JACK THOMAS
K964988 03/06/1997 COULTER AC.T SERIES ANALYZER COULTER CORP. THOMAS J ENGLISH
K964939 03/06/1997 THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS CREATIVE BIOMEDICS, INC. DANIEL BROWN
K960842 03/19/1997 LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) CROCKER INDUSTRIAL RESOURCES SDN. BHD. TIMOTHY F HAND
K964971 03/28/1997 CRYOGEN CRYOSURGICAL SYSTEM CRYOGEN, INC. JOHN DOBAK
K964336 03/20/1997 CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680 CRYOMEDICAL SCIENCES, INC. RICHARD J REINHART
K964737 03/19/1997 HYDROPREP GEL D.O. WEAVER CO. DAVID O WEAVER
K970101 03/04/1997 JAMES ALEX SUNGLASSES D&K STORES, INC. ROBERT DWECK
K970387 03/10/1997 HUMAN CHORIONIC GONADOTROPIN METHOD DADE CHEMISTRY SYSTEMS, INC. REBECCA S AYASH
K970336 03/03/1997 MMB CALIBRATOR DADE CHEMISTRY SYSTEMS, INC. CATHY P CRAFT
K970393 03/03/1997 THYROID STIMULATING HORMONE METHOD DADE CHEMISTRY SYSTEMS, INC. REBECCA S AYASH
K964346 03/28/1997 PARAMAX TRIGLYCERID REAGENT DADE INTL., INC. MARIAN HARDING COCHRAN, ESQ.
K964987 03/17/1997 DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 DATASCOPE CORP. KEVIN CROSSEN
K970037 03/12/1997 TARGOGRID DAUM GMBH E.J. Smith
K964879 03/04/1997 PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM DAVOL, INC., SUB. C.R. BARD, INC. ROBIN DRAGO
K963174 03/13/1997 HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) DEL MAR AVIONICS RAPHAEL HENKIN, PH.D.
K970433 03/27/1997 AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K964046 03/04/1997 DENTSPLY PRECISION TORQUE SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K970202 03/21/1997 DEPUY ACE AIM TITANIUM TIBIAL NAIL DEPUY ACE MEDICAL CO. PAUL DONER
K965145 03/13/1997 DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DEPUY, INC. CHERYL HASTINGS
K964024 03/26/1997 DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM DEPUY, INC. CHERYL HASTINGS
K962628 03/18/1997 MOSS MIAMI SPINAL SYSTEM DEPUY, INC. CHERYL HASTINGS
K964915 03/26/1997 MAGNESIUM DERMA MEDIA LAB., INC. CHARLES C ALLAIN, PH.D.
K965127 03/17/1997 DGH MODEL 9000 DGH TECHNOLOGY, INC. EARL W HENDERSON
K962323 03/10/1997 IMMULITE OPIATES SCREEN/CONTROL MODULE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K970402 03/26/1997 DOCTORS REVIEW SYSTEM DIGISONICS, INC. DIANA MC SHERRY, PH.D
K965120 03/21/1997 ALLCLENZ WOUND CLEANSER DPT LABORATORIES, LTD. RICHARD A HAMER
K963994 03/19/1997 NARKOMED GS ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. JAMES J BRENNAN
K970440 03/27/1997 EKONIC DENTAL/MEDICAL MASK (MD 610) EKONIC COMPANY, LTD. WILLIE YUNG
K965203 03/17/1997 RADX SYSTEM ELECTRO MEDICAL SYSTEMS, INC. STEVEN A CLARKE
K964385 03/06/1997 ELIAS ANA-HEP-2 ELIAS USA, INC. GOTTFRIED KELLERMANN, PH.D.
K970005 03/28/1997 GYREX 2T-PRESTIGE ELSCINT, INC. THOMAS J SPACKMAN
K961360 03/13/1997 TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM ENCORE ORTHOPEDICS, INC. ASHLEY BOCK
K970357 03/10/1997 EPISCREEN EPITOPE, INC. CAROLINE R SAYRE, RAC
K965015 03/14/1997 TOPAZ 30 SURGICAL LASER SYSTEM ESC MEDICAL SYSTEMS, INC. HILLEL BACHRACH
K970079 03/11/1997 PROXIMATE DISPOSABLE SKIN STAPLER ETHICON ENDO-SURGERY, INC. LORRI CHAVEZ
K970424 03/06/1997 EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST EXCEL SCIENTIFIC, INC. MIN-LEE CHENG
K970467 03/18/1997 EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT EXCEL SCIENTIFIC, INC. MIN-LEE CHENG
K970425 03/06/1997 EZ SURE URINE DIPSTICK PREGNANCY HOME TEST EXCEL SCIENTIFIC, INC. MIN-LEE CHENG
K963894 03/11/1997 SMARTGUIDE FERGUSON MEDICAL FRANK FERGUSON
K964806 03/04/1997 MD-1835 FISCHER IMAGING CORP. WILLIAM J ENGEL
K970240 03/11/1997 DIFFUSER PANEL FOCUSED VIEWER, INC. WILLIAM BRAUER, M.D.
K970293 03/21/1997 FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K970349 03/31/1997 FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K963057 03/21/1997 FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K970063 03/11/1997 SERIES 7600 MOBILE DIGITAL C-ARM GE DEC MEDICAL SYSTEMS TED L PARROT
K962781 03/06/1997 COROMETRICS MODEL 510 AND 511 MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARIA V FOUTS
K964973 03/10/1997 GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR GISH BIOMEDICAL, INC. JEFF DUMONTELLE
K964387 03/27/1997 POINT OF USE II SHARPS-A-GATOR GRAPHIC CONTROLS CORP. GEORGE AUSTRIA
K962343 03/24/1997 TOXO IGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD, PH.D.
K964441 03/28/1997 FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU GYNECARE INNOVATION CENTER MICHAEL A DANIEL
K961151 03/19/1997 SPINAL NEEDLES HAKKO SHOJI CO., LTD. JOHN ROGERS
K961152 03/19/1997 TUOHY EPIDURAL NEEDLES HAKKO SHOJI CO., LTD. JOHN ROGERS
K964966 03/05/1997 V-CATH HDC CORP. GRETCHEN MARCHESANI
K965051 03/12/1997 HEARTPORT NEEDLE TROCAR HEARTPORT, INC. MARIANNE C DRENNAN
K970161 03/25/1997 HEDGES CORNEAL WETTING PAK HEDGES CWP, INC. DAVID JASPAN
K965163 03/19/1997 CUTTERSIL COMFORT HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K965165 03/19/1997 CUTTERSIL COMFORT HARDENER HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K963706 03/19/1997 PHILIPS SONO DIAGNOST 800 HEWLETT-PACKARD CO. PAUL SCHRADER
K970034 03/17/1997 SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM HEWLETT-PACKARD CO. PAUL SCHRADER
K965175 03/13/1997 HOWMEDICA MAINSTAY ANCHOR HOWMEDICA CORP. JOHN DICHIARA
K965164 03/13/1997 HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR HOWMEDICA CORP. MARGARET F CROWE
K962730 03/07/1997 HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962728 03/07/1997 HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962731 03/07/1997 HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962729 03/07/1997 HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962727 03/07/1997 HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962720 03/07/1997 HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962722 03/07/1997 HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962719 03/07/1997 HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K962578 03/07/1997 HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY HYCOR BIOMEDICAL, INC. MEHDI ALEM, PH.D.
K965055 03/06/1997 IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES IMAGYN MEDICAL, INC. DEBRA A RINDERER
K965077 03/17/1997 SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K964882 03/13/1997 IMPLEX REPLACEMENT ACETABULAR CUP INSERT IMPLEX CORP. JAMES E MALAYTER
K964877 03/20/1997 IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT IMPRA, INC. KRISTI M KISTNER
K963495 03/03/1997 IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM IMZ, GMBH ROBEERT J SLOMOFF
K963522 03/03/1997 IMZ 2000 INTERLOCK 12/3 - SCREW IMZ, GMBH ROBERT J SLOMOFF
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K970904 03/26/1997 WIDEX SENSO DIGITAL (CIC) WIDEX HEARING AID CO., INC. RON MELTSNER
K963587 03/24/1997 WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) WRIGHT MEDICAL TECHNOLOGY, INC. ROBERT CHURINETZ
K964909 03/10/1997 ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS XOMED, INC. DAVID TIMLIN


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