FDA 510(k) Decisions During April, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K963863 04/21/1997 JANUS I 3D ULTRASOUND, INC. JOHN OXAAL
K970500 04/30/1997 3M SUSTEL DENTAL SYSTEM 3M COMPANY REBECCA L HANNACK
K970796 04/09/1997 3M RED DOT 2560 & 2570 MONITORING ELECTRODES 3M HEALTH CARE LINDA JOHNSEN
K970820 04/25/1997 ETEST SPARFLOXACIN AB BIODISK ANNE BOLMSTROM
K970492 04/09/1997 INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER ACKRAD LABORATORIES BERNARD ACKERMAN, PH.D.
K970462 04/03/1997 ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM ACROMED CORP. SLLY LEVINE
K970350 04/22/1997 "EQUI-PISE 1000 MRS" ADVANCED AIR SUPPORT CONSULTANCY, INC. LEONARD C HIGGS
K961972 04/18/1997 MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR AEQUITRON MEDICAL, INC. ROBERT C SAMEC
K964281 04/21/1997 AESCULAP ANGLED NEUROENDOSCOPES AESCULAP, INC. MARY ELLEN HOLDEN
K970549 04/30/1997 TITANIUM ALLOY BONE SCREWS AESCULAP, INC. VICTORIA MACKINNON
K964956 04/23/1997 E-Z SPACER MASK (SMALL) AIRPHARMA, LLC TOM EVANGELISTI
K970033 04/23/1997 MONARCH IOL DELIVERY SYSTEM ALCON LABORATORIES MARTIN A KAUFMAN
K963305 04/17/1997 ALEXANDER BOX, BATTERY, RECHARGEABLE ALEXANDER MFG. CO. STACEY HIPPEN
K970271 04/02/1997 ALEXANDER MANUFACTURING COMPANY ALEXANDER MFG. CO. STACEY HIPPEN
K970921 04/08/1997 STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) ALKO DIAGNOSTIC CORP. JANET A MCGRATH
K970827 04/16/1997 PRECISE ALLAN SCHULMAN,D.D.S., M.S. ALLAN SCHULMAN
K970399 04/03/1997 KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) ALLEGIANCE HEALTHCARE CORP. MARYALICE SMITH
K963616 04/03/1997 ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. PAUL D SMOLENSKI
K964400 04/28/1997 ALPHATEC EXTERNAL FIXATION SYSTEM ALPHATEC MFG., INC. KENNETH J KISCO
K964900 04/14/1997 "RAPID DRUG SCREEN" AMERICAN BIO MEDICA CORP. HENRY WELLS
K965205 04/30/1997 TEFGEN - LS AMERICAN CUSTOM MEDICAL, INC. BRUCE G RUEFER
K970932 04/08/1997 ORGENTEC MICRO-ALBUMIN EIA ASSAY AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD CONLEY
K970133 04/14/1997 AMERIGEL OINTMENT AMERX HEALTH CARE CORP. RONALD L MADDIX
K965095 04/22/1997 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE ANSELL EDMONT INDUSTRIAL, INC. MIKE W HAGANS
K970429 04/29/1997 BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T APEX MEDICAL CORP. DANIEL LEE
K963886 04/24/1997 "EVS" APPLIED MEDICAL RESOURCES HOWARD V ROWE
K960928 04/04/1997 SYRINGEFILTER ARBOR TECHNOLOGIES, INC. DAWN I MOORE
K953982 04/25/1997 SIMPLEX TENS ARMSTRONG INDUSTRIES, INC. JOHN LANDINO
K964849 04/14/1997 ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM ARTHROCARE CORP. CHERYL L SHEA
K970493 04/30/1997 HYFRECATOR 2000 ASPEN LABS CHARLES M HART
K970205 04/21/1997 VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY AUSTENAL, INC. RONALD DUDEK
K964742 04/22/1997 RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM AZIZ Y. ANIS, M.D. GLENN A DUNKI-JACOBS
K970453 04/11/1997 B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING B. BRAUN MEDICAL, INC. DIANE HOCHREIN
K970287 04/07/1997 LUMBAR PUNCTURE KIT B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K962696 04/03/1997 PERIFIX PEDIATRIC EPIDURAL KIT B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K964151 04/16/1997 BARD AND BTA TEST BARD DIAGNOSTIC SCIENCES,INC. GLEN P FREIBERG
K970438 04/02/1997 INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS BAXTER HEALTHCARE CORP. MARY E SNYDER
K971209 04/04/1997 CLINITEK HCG TEST STRIPS BAYER CORP. ROSEANNE SAVOL
K970209 04/18/1997 CAPNOCHECK PLUS BCI INTL., INC. DONALD J ALEXANDER
K964654 04/02/1997 BECTON DICKINSON BLUNT PLASTIC CANNULA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K964695 04/29/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT BECKMAN INSTRUMENTS, INC. FRANK MARTE
K964766 04/25/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K965033 04/21/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K964762 04/25/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K965035 04/17/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K970314 04/21/1997 SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS BECKMAN INSTRUMENTS, INC. KATHLEEN M JAKER
K971210 04/17/1997 SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS BECKMAN INSTRUMENTS, INC. FRANK MARTE
K970259 04/08/1997 E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET BECTON DICKINSON VASCULAR ACCESS, INC. C.J. WELLE
K970095 04/03/1997 PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS BIOCOMPATIBLES EYEWEAR, INC. SHIRLEY MCGARVEY
K970897 04/21/1997 BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K964887 04/08/1997 VIDAS C. DIFFICILE TOXIN A II ASSAY BIOMERIEUX VITEK, INC. TERRY MCGOVERN
K964970 04/03/1997 BIOMET BONE SCREW BIOMET, INC. MARY L VERSTYNEN
K961260 04/02/1997 KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY BIOMET, INC. PATRICIA S BERES
K970501 04/30/1997 PEGGED ACETABULAR COMPONENT BIOMET, INC. PATRICIA S BERES
K970204 04/29/1997 BK-A; BK-B; BK-IS SEALING CAP BIOTRONIK, INC. JOSEPH J SCHWOEBEL
K962571 04/22/1997 COAGUCHEK PST SYSTEM BOEHRINGER MANNHEIM CORP. MICHAEL FLIS
K970984 04/02/1997 THE ELECSYS CALCHECK PROGESTERONE BOEHRINGER MANNHEIM CORP. YVETTE LLOYD
K964534 04/09/1997 OTOSILK OTOLOGICAL GRAFT DRESSING BOSTON MEDICAL PRODUCTS, INC. STUART K MONTGOMERY
K970278 04/11/1997 MICROVASIVE GOLD PROBE BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K970121 04/02/1997 STONE DISLODGER, BASKET BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K964119 04/28/1997 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS BOSTON SCIENTIFIC SCIMED, INC. CATHY YOHNK
K970574 04/24/1997 ACUPUNCTURE NEEDLES C.A.I. INDUSTRIES CORP. LU RAO
K960553 04/22/1997 CARD GUARD MODEL CG-900 CARD GUARD SCIENTIFIC SURVIVAL, LTD. ANNE LAURITZEN
K963503 04/03/1997 CTS MIDCAB CORONARY SHUNT CARDIOTHORACIC SYSTEMS, INC. MICHAEL J BILLIG
K970719 04/16/1997 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES CARDIOTRONICS SYSTEMS, INC. TIM J WAY
K963989 04/24/1997 P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE CARDIOVASCULAR DYNAMICS, INC. MICHAEL CROCKER
K965139 04/23/1997 SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM CARL ZEISS, INC. KENNETH M NICOLL
K971323 04/21/1997 ALT OR SGPT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971344 04/21/1997 AST OR SGOT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971363 04/21/1997 SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K971133 04/14/1997 URIC, UA, OR URIC ACID CAROLINA LIQUID CHEMISTRIES CORP. CYNTHIA SHUGART
K970616 04/21/1997 MINI SAMPLER PROCESSOR CAVRO SCIENTIFIC INSTRUMENTS, INC. FRED WOLCOTT
K964193 04/16/1997 CHASE AORTIC ARCH CANNULA CHASE MEDICAL, INC. BERT DAVIS
K964194 04/16/1997 CHASE CURVED LEFT HEART VENT CATHETER CHASE MEDICAL, INC. BERT DAVIS
K964200 04/16/1997 CHASE MULTIPLE PERFUSION SET CHASE MEDICAL, INC. BERT DAVIS
K964393 04/23/1997 CHASE RETROGRADE CARDIOPLEGIA CANNULA CHASE MEDICAL, INC. BERT DAVIS
K971022 04/17/1997 CHASE SUCKER CHASE MEDICAL, INC. BERT DAVIS
K970956 04/08/1997 CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 CHIRON DIAGNOSTICS CORP. THOMAS F FLYNN
K970979 04/02/1997 LIQUID CSF(LCR)1, LIQUID CSF(LCR)2 CHIRON DIAGNOSTICS CORP. RONALD D SCHAEFER
K971071 04/23/1997 LIQUID LIGAND 1,2,3 CHIRON DIAGNOSTICS CORP. RONALD D SCHAEFER
K954547 04/01/1997 CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER CITIZEN WATCH CO., LTD. HOWARD M HOLSTEIN
K970930 04/23/1997 BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE CLEFT PALATE APPLIANCES, INC. ELIZABETH ANN LATHAM
K970603 04/01/1997 D SERIES ELECTRODE CMC SENSE-IT, INC. CLARK VIER
K955592 04/30/1997 COBE CENTRYSYSTEM 14 PES HEMODIALYZERS COBE RENAL CARE, INC. JEFFREY R SHIDERMAN
K955487 04/18/1997 GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS COBE RENAL CARE, INC. JEFFREY R SHIDEMAN
K970764 04/22/1997 COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES COMEG ENDOSCOPY KAELYN HADLEY
K963126 04/07/1997 "AESOP SYSTEM AND ACCESSORIES" COMPUTER MOTION, INC. DOUGLAS P BUESCHEL
K971040 04/16/1997 CABLE HOLDER, SUCTION TUBE HOLDER CONTOUR FABRICATORS, INC. MICHEAL CZOP
K970185 04/10/1997 STERILE DISPOSABLE EQUIPMENT MAGNET COVER CONTOUR FABRICATORS, INC. MICHAEL CZOP
K970392 04/24/1997 CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM CORDIS CORP. ELENA S JUGO
K970299 04/24/1997 JUPITER PTA CATHETERS (VARIOUS) CORDIS CORP. MARTINE D SCHNEIDER
K965113 04/16/1997 N-ASSAY TIA FIBRINOGEN TEST KIT CRESTAT DIAGNOSTICS, INC. MARY REES
K964989 04/02/1997 CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) CRITICAL DEVICE CORP. DAN HYUN
K964918 04/14/1997 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS CRITICAL DEVICE CORP. DAN HYUN
K971141 04/28/1997 FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM DADE CHEMISTRY SYSTEMS, INC. CATHY P CRAFT
K970330 04/14/1997 DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE DADE INTL., INC. CAROLYN K GEORGE
K964715 04/25/1997 PARAMAX SALICYLATE REAGENT DADE INTL., INC. MARIAN HARDING COCHRAN
K955026 04/28/1997 AS/3 NMT MODULE DATEX MEDICAL INSTRUMENTATION, INC. JOEL KENT
K963850 04/22/1997 PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM DEKNATEL, INC. DEAN E CIPORKIN
K970342 04/04/1997 CAVITRON JET WITH SPS SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K970123 04/11/1997 DENTSPLY CAVITRON SPS SCALER SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K962814 04/14/1997 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMATERIALS, INC. LYNNE LEONARD
K970503 04/30/1997 DEPUY ACE TROCHANTERIC SIDE PLATE DEPUY ACE MEDICAL CO. KATHLEEN A DRAGOVICH
K971005 04/21/1997 TRIGLYCERIDES DERMA MEDIA LAB., INC. CHARLES C ALLAIN
K970867 04/21/1997 URIC ACID REAGENT DERMA MEDIA LAB., INC. CHARLES C ALLAIN
K970289 04/15/1997 COMPRESSOR/NEBULIZER #3650 DEVILBISS HEALTH CARE, INC. FRANK CLEMENTI
K963916 04/28/1997 IMMULITE CANNABINOIDS DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D.
K963918 04/08/1997 IMMULITE COCAINE METABOLITE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D.
K963613 04/02/1997 IMMULITE RUBELLA IGG DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K971051 04/10/1997 IMMULITE THYROID AUTOANTIBODY CONTROL MODULE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K962936 04/24/1997 IMMULITE TOXOPLASMA QUANTITATIVE IGG DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K970701 04/02/1997 DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) DIAGNOSTIC SYSTEMS LABORATORIES, INC. JONH WILLIS
K970228 04/08/1997 IS-ANTI-JO-1 TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K970239 04/08/1997 IS-ANTI-SCL-70 TEST SYSTEM (720-280) DIAMEDIX CORP. LYNNE STIRLING, PH.D.
K970220 04/08/1997 IS-ANTI-SM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING, PH.D.
K970238 04/08/1997 IS-ANTI-SM/RNP (720-270) DIAMEDIX CORP. LYNNE STIRLING, PH.D.
K970218 04/08/1997 IS-ANTI-SSA TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING, PH.D.
K970237 04/08/1997 IS-ANTI-SSB TEST SYSTEM (720-260) DIAMEDIX CORP. LYNNE STIRLING
K971120 04/14/1997 DISPENS-O-DISC (TM) LEVOFLOXACIN DIFCO LABORATORIES, INC. DAVID W GATES
K971211 04/14/1997 DISPENS-O-DISC SPARFLOXACIN DIFCO LABORATORIES, INC. DAVID W GATES
K970227 04/08/1997 IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER DPC CIRRUS ROBERT M DI TULLIO
K954204 04/25/1997 DRAGER INCUBATOR 8000 IC DRAGER, INC. HARALD KNEUER
K970265 04/08/1997 ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST DRIAL CONSULTANTS, INC. CLEVE W LAIRD, PH.D.
K970180 04/25/1997 VSA 3000 VIBRATORYN SENSORY ANALYZER EARE CONSULTING SERVICE EMANUEL A ROSEN, M.S., R.PH.
K970154 04/04/1997 KODAK EKTASIAN HG FILM (EHG-15) EASTMAN KODAK COMPANY MARIA DURKIN
K970290 04/01/1997 EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM EBI, L.P. JON CAPAROTTA
K970108 04/03/1997 HARMONIES MENSTRUAL TAMPON ECOPROGRESS INTL. LARRY C SHATTLES
K964533 04/09/1997 EBI SPINELINK SYSTEM ELECTRO-BIOLOGY, INC. SHARON A STAROWICZ
K970291 04/24/1997 ACCESSORIES TO THE STEREOTACTIC BODY FRAM ELEKTA INSTRUMENT AB SVERKER GLANS
K970381 04/18/1997 POWERED TOOTHBRUSH EMJOI ACTION USA, LTD. JAMES R MARSHALL, PH.D.
K970203 04/14/1997 EPIX VT EMPI STACY MATTSON
K970307 04/22/1997 MINNOVA PELVIC FLOOR STIMULATION SYSTEM EMPI CAROLYN M STEELE HUSTEN
K970031 04/02/1997 FOUNDATION KNEE SYSTEM TIBIAL COMPONENT ENCORE ORTHOPEDICS, INC. ASHLEY M BOCK
K963731 04/22/1997 TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT ENTHERMICS MEDICAL SYSTEMS, INC. JAMES DIRKSEN
K964253 04/11/1997 DERMA 20 LASER SYSTEM ESC MEDICAL SYSTEMS LTD. ZVI LADIN
K970317 04/25/1997 MODIFIED E-PACK PROCEDURE KIT ETHICON, INC. JOHN D PAULSON, PH.D.
K970524 04/22/1997 SAFE-CONNECT I.V. EXTENSION SET FAULDING MEDICAL DEVICE CO. BRUCE CRANEY
K960421 04/16/1997 SINUSCAN 102/SINUSPRINT FERGUSON MEDICAL FRANK FERGUSON
K970272 04/11/1997 PATIENT RESTRAINT FLA. ORTHOPEDICS, INC. RHONDA FALK
K970273 04/11/1997 PATIENT RESTRAINTS FLA. ORTHOPEDICS, INC. RHONDA FALK
K970274 04/11/1997 PATIENT RESTRAINTS FLA. ORTHOPEDICS, INC. RHONDA FALK
K970275 04/11/1997 PATIENT RESTRAINTS FLA. ORTHOPEDICS, INC. RHONDA FALK
K970312 04/02/1997 CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) FLEXLENS, INC. KEVIN M RANDALL
K970010 04/01/1997 FPT NEBULIZER FLUID PROPULSION TECHNOLOGIES, INC. GEORGE JOHNSON
K961388 04/03/1997 ATLAS III ACETABULAR CUP FOURNITURES HOSPITALIERES BEN VAN DER KOOIJ
K963996 04/24/1997 (FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400 FULL SPECTRUM, INC. GERALD J SHIRK
K963991 04/24/1997 FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS FULL SPECTRUM, INC. GERALD J SHIRK, M.D.
K963601 04/28/1997 MODEL 1920 WASTE GAS SCAVENGER G. DUNDAS CO. MARIO SORCI
K962788 04/30/1997 CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM GAYMAR INDUSTRIES, INC. PETER SCOTT
K970656 04/08/1997 HYDROFLEX GC AMERICA, INC. TERRY L JORITZ
K970606 04/04/1997 COMPUTED TOMOGRAPHY X-RAY SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K970303 04/25/1997 SATURNE MULTILEAF COLLIMATOR GENERAL ELECTRIC CO. LARRY A KROGER
K970201 04/21/1997 GSI CANNULA WITH INTRODUCER GENERAL SURGICAL INNOVATIONS CATHLEEN MANTOR
K971122 04/25/1997 ACCULINE PREGNANCY TEST GENIX BIOTEK, INC. RICHARD WANG
K964382 04/15/1997 HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) GIBECK, INC. CHYRELL SAUNDERS
K964377 04/23/1997 THERMAL REGULATION SYSTEM BLANKET GIBECK, INC. ELAINE M HEAZELTINE
K970525 04/16/1997 STATNET GORCA SYSTEMS, INC. DONALD G HERZOG
K970035 04/01/1997 JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 GRAHAM-FIELD, INC. SUSAN D GOLDSTEIN-FALK
K970608 04/21/1997 EVT MARKER BOARD GUIDANT CARDIAC AND VASCULAR SURGERY LUANNE TERMEER
K965183 04/24/1997 VANTAGE PERIPHERAL DILATATION CATHETER GUIDANT CORP. MONA MIRAPURI
K963793 04/16/1997 OPTIVENT HEALTHCARE PRODUCTS, INC. LAUREN R ZIEGLER
K970173 04/16/1997 MODEL 1700 TRANQUILITY BILEVEL SYSTEM HEALTHDYNE TECHNOLOGIES, INC. TIMOTHY Y COWART
K964161 04/04/1997 HEARTPORT ENDOAORTIC CLAMP HEARTPORT, INC. KEVIN F MACDONALD
K970373 04/17/1997 RAICHEM RHEUMATOID FACTOR SPIA HENAGE DIAGNOSTICS, INC. JOSEPH M CALLIFABO
K964038 04/02/1997 CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG HERAEUS KULZER, INC. CHERYL ZIMMERMAN
K970886 04/16/1997 HANAULUX BLUE 80 HOSPITAL HERAEUS MED GMBH MARK SCHULZ
K964309 04/22/1997 SONOS 2000, SONOS 2500 (M2406 A) HEWLETT-PACKARD CO. PAUL SCHRADER
K970074 04/03/1997 STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) HILL-ROM, INC. JAMES G CARPENTER
K970144 04/22/1997 VINYL EXAM GLOVE POWERED HIYI EXPORT CO. JANNA P TUCKER
K970602 04/15/1997 VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL HOLLISTER, INC. JOSEPH S TOKARZ
K970200 04/09/1997 RELIANCE PF FEMORAL STEMS HOWMEDICA CORP. FRANK MAAS
K970911 04/11/1997 LEE PLATE HOWMEDICA LEIBINGER, INC. KRISTYN WASKI
K963030 04/11/1997 LEIBINGER IMF SCREW HOWMEDICA LEIBINGER, INC. ANDREW B ROGERS
K970626 04/04/1997 EASY CAM I.C.S. ALAN CREAMER
K964435 04/02/1997 PRIMARY IV SET ICU MEDICAL, INC. RICHARD WATERS
K971255 04/21/1997 IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER IMAGYN MEDICAL, INC. DEBRA A RINDERER
K970156 04/04/1997 IMEX FUTURALDOP PRO IMEX MEDICAL SYSTEMS, INC. DAVID W WAGNER
K970378 04/30/1997 STRYKER 2115 REPLACEMENT BATTERY (2115) IMPLANT RESOURCE, INC. MICHAEL HOLLOWAY
K970447 04/30/1997 IMPLEX BIPOLAR HIP SYSTEM IMPLEX CORP. JAMES E MALAYTER
K971192 04/15/1997 IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT IMPRA, INC. KRISTI M KISTNER
K970841 04/30/1997 IMTEC/TITANIUM MESH IMTEC CORP. M.K. PATTERSON
K970334 04/25/1997 NATURE'S CRADLE INFANT ADVANTAGE, INC. GERALD V BEEMILLER
K970292 04/23/1997 IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW INFLUENCE, INC. PETER BICK
K970754 04/21/1997 INNERDYNE STEP TROCAR EXPANABLE PORT, "OPEN STEP" INNERDYNE, INC. RICK GAYKOWSKI
K970316 04/16/1997 INNOVASIVE 8MM LIGAMENT FASTENER INNOVASIVE DEVICES, INC. ERIC BANNON
K970423 04/30/1997 INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE INNOVASIVE DEVICES, INC. ERIC BANNON
K962638 04/04/1997 TONOCAP, TC-200 AND ACCESSORY CATHETERS INSTRUMENTARIUM CORP. JOEL KENT
K970166 04/08/1997 NATURAL-HIP SYSTEM COCR REVISION STEM INTERMEDICS ORTHOPEDICS LORI K HOLDER
K970498 04/30/1997 NATURAL-KNEE II REVISION FEMORAL SPACER LUGS INTERMEDICS ORTHOPEDICS MITCHELL A DHORITY
K963593 04/22/1997 IMT LOUPE-COLPOSCOPE INVENTIVE MEDICAL TECHNOLOGY THEODORE P REED
K964074 04/01/1997 DIOLITE 532 IRIDERM DIV. THEODORE A BOUTACOFF
K961924 04/11/1997 IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM IRVINE BIOMEDICAL, INC. PETER CHEN
K970485 04/21/1997 SMARTSITE ACCESS PIN IVAC MEDICAL SYSTEMS RENEE L FLUET
K970963 04/30/1997 TARGIS ALLOY #7 IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K971128 04/28/1997 CAP-35B III/CINE 275 JAMIESON FILM CO. GARY W FULLER
K970941 04/16/1997 SLIPPERY GLASS JENERIC/PENTRON, INC. MURRAY G GAMBERG
K970894 04/14/1997 VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. ANN M QUINN
K964556 04/16/1997 HR POLYURETHANE PICC AND MIDLINE CATHETERS JOHNSON & JOHNSON MEDICAL, INC. PHYLLIS ELSON
K970246 04/16/1997 EDTA CAVIT KAROLINSKI SVEN LINDSKOG
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K954120 04/02/1997 MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR MAGNETIC RESONANCE EQUIPMENT CORP. G. RONALD MORRIS
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K963948 04/08/1997 MINIMED INSULIN PUMP, MODEL 505 MEDTRONIC MINIMED DON SELVEY
K970341 04/23/1997 MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT MEDTRONIC PS MEDICAL TOM HOLDYCH
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K970778 04/17/1997 LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 MORE DIAGNOSTICS JAMES W SNIPES
K970534 04/04/1997 PICTURE ARCHIVING & COMMUNICATIONS DEVICE MULTIMEDIA SOLUTIONS LAURENCE TRICE
K970116 04/02/1997 ESG-1 ELECTROSONOGRAM (ESG-1) MYO-TRONICS, INC. FRAY ADIB
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K970953 04/15/1997 E-TYPE SPEED REDUCER CONTRA ANGLE NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K970288 04/24/1997 CLINICAL DIAGNOSTIC SOFTWARE NUCCARDIAC SOFTWARE, INC. KENNETH F VANN TRAIN
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K970369 04/14/1997 VISTA MINI CAMERA SYSTEM OKTAS MARTIN NEWMAN
K970563 04/11/1997 OLYMPUS NA-10J-1 ASPIRATION NEEDLE OLYMPUS AMERICA, INC. SUBHASH R PATEL
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K963631 04/02/1997 SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 OMEGA RESULTS KAY SPIEKERMAN EASON
K964365 04/22/1997 RESECTOSCOPE CUTTING LOOP ELECTRODE OMNITECH SYSTEMS, INC. GENE S ESTILL
K961790 04/09/1997 POINT-OF-CARE BLOOD GAS MONITOR SYSTEM OPTICAL SENSORS, INC. DENISE A SSCHOTTLER
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K970697 04/24/1997 OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM OSTEONICS CORP. KATE SUTTON
K970394 04/22/1997 OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM OSTEONICS CORP. TERRY SHERIDAN
K954730 04/01/1997 BENCHMARK TRANSFER TEST P.K. MORGAN LTD. R. H JKERNAGHAN
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K964288 04/23/1997 CALL-RAD PC TELERADIOLOGY PC TELERADIOLOGY G.N. BALDWIN, M.D.
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K970975 04/01/1997 PROSTYLE INTRA PLANMECA OY LARS MORING
K970418 04/29/1997 PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) PMT CORP. EDWARD F VALDEZ
K970781 04/21/1997 LIQUID GLUCOSE (OXIDASE) REAGENT SET POINTE SCIENTIFIC, INC. WILLIAM F WALTERS
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K961156 04/01/1997 ONCE-A-DAY BOWIE AND DICK TEST PACK. PROPPER MFG. CO., INC. THOMAS A AUGURT, PH.D.
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K970331 04/16/1997 CBC-4K HEMATOLOGY CONTROL R & D SYSTEMS, INC. SUE GALLO
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K970924 04/01/1997 REGENT BIOGEL SURGICAL GLOVE, BIOGEL "M" GLOVE REGENT MEDICAL NEIL ANDERSON
K971228 04/09/1997 FEMTEX 100% COTTON TAMPONS REGU-TECH ASSOC., INC. ROBERT J STAAB
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K970345 04/29/1997 ALIGNMENT INSTRUMENT RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K970088 04/07/1997 RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K955666 04/15/1997 EGS4000 S&P ELECTRICAL INDUSTRIES, INC. SUSAN D GOLDSTEIN-FALK
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K960764 04/24/1997 SAFE-CATH SCIENTIFIC DEVICE MANUFACTURER LLC. RICHARD C BELL
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K962627 04/03/1997 CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K970734 04/21/1997 SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. JING ZHANG
K962882 04/24/1997 SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. STEVE HESLER
K970931 04/24/1997 COPALIS TORC TOTAL ANTIBODY ASSAY SIENNA BIOTECH, INC. JUDITH J SMITH
K970966 04/22/1997 COMFORT CATH CHOICE MALE EXTERNAL CATHETER SIERRA LABORATORIES, INC. ANNA PEREZ
K971092 04/23/1997 QA-ES SMITH E.J. SMITH
K970416 04/21/1997 ACUFEX DOUBLE ARMED SUTURE NEEDLE SMITH & NEPHEW ENDOSCOPY, INC. SUSAN A FINNERAN
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K970533 04/15/1997 MODEL 1100 COLD THERAPY DEVICE SMITH & NEPHEW, INC. DAN W MILLER
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K970751 04/16/1997 HEIDELBERG EXTERNAL FIXATOR SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. JOANNE KHUNE
K964254 04/21/1997 TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K970090 04/21/1997 SOLO-SLED SOLO-SLED, LLC. PATRICIA A RODDY
K970800 04/02/1997 MAXCESS NEEDLEFREE - Y- SITE (100713) SOLOPAK MEDICAL PRODUCTS, INC. ELIZABETH LOYA
K970576 04/09/1997 SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) SOMNUS MEDICAL TECHNOLOGIES, INC. EVE A CONNER, PH.D.
K962930 04/25/1997 SPACELABS MEDICAL ECG ANALYSIS SYSTEM SPACELABS MEDICAL, INC. RUSS GARRISON
K952912 04/02/1997 SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE SPACELABS MEDICAL, INC. RUSS GARRISON
K963755 04/08/1997 SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR SPIRACLE TECHNOLOGY GEORGE P MESSING
K970164 04/15/1997 ROLL AID STAND AID OF IOWA, INC. MIKE KLEINWOLTERINK
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K953122 04/02/1997 STERITEC DRY HEAT INDICATOR LABEL STERITEC PRODUCTS MFG. CO., INC. TOM ROLL
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K970580 04/17/1997 SASI-DC1TS SUBSTANCE ABUSE SPECIALTIES, INC. LIBBY HAMILTON
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K971142 04/28/1997 ADVENTURER T.E.S., LTD. JIM COCKS
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K951640 04/21/1997 HUMAN PROTEIN S RID TEST KIT THE BINDING SITE, LTD. JAY H GELLER
K970969 04/23/1997 KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET THE KENDAL CO. DAVID A OLSON
K970255 04/14/1997 KIPP MED I.V. MANIFOLD THE KIPP GROUP J EDWARD GUILMETTE
K964585 04/17/1997 RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE) TRIMEDYNE, INC. SUSAN H GAMBLE
K970422 04/21/1997 RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS TRIMEDYNE, INC. SUSAM H GAMBLE
K970370 04/10/1997 TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE TSK LABORATORY, JAPAN NORMAN S JOHNSON
K970284 04/21/1997 ARTOS, DIPLOS SYSTEM TURNKEY INTERGRATION USA, INC.
K970328 04/21/1997 ULTRACELL NEURO SPONGES ULTRACELL MEDICAL TECHNOLOGIES, INC. GEORGE P KORTEWEG
K970113 04/02/1997 ULTRA-BLEND PLUS ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K970519 04/24/1997 UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K970607 04/25/1997 UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA UNIVERSAL REAGENTS, INC. JORGE MILLER
K970593 04/25/1997 UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA UNIVERSAL REAGENTS, INC. JORGE MILLER
K963589 04/21/1997 VAIL 3000 BED ENCLOSURE VAIL PRODUCTS, INC. NANCY VAIL
K962700 04/09/1997 VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT VASAMEDICS, L.L.C. DOUGLAS G TOMASKO
K955653 04/11/1997 VENISECT LASER LANCET VENISECT, INC. LAURIE A RIDENER
K941707 04/21/1997 ANTI-MUSCLE ACTIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. KURT REINHARDT
K941170 04/22/1997 VENTANA ANTI-MELANOMA PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN TILLSON
K941514 04/25/1997 VENTANA ANTI-S100 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN TILLSON
K965199 04/30/1997 TUNA 5 CATHETER VIDAMED, INC. NOEL MESSENGER
K962937 04/10/1997 CARDIO TEAM II VISION ELECTRONICS SHAWN P WOOD
K970217 04/02/1997 VISTA ILLUMINATION SYSTEM VISTA MEDICAL TECHNOLOGIES, INC. MARTIN NEWMAN
K970755 04/15/1997 STEALTHSHIELD VITAL CONNECTIONS, INC. MARK L MEISTER
K970985 04/21/1997 WAKO TOTAL BILIRUBIN V WAKO CHEMICALS, USA, INC. TONYA MALLORY
K964756 04/23/1997 PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT WANO-TECH CORP. K. PETER MOSSNER
K970382 04/17/1997 VS-100 VIDEO SIGMOIDOSCOPE WELCH ALLYN, INC. LAWRENCE E MAROCCO
K970743 04/30/1997 BCW POWER ADVANTAGE WHEELCHAIR WHEELCHAIRS OF KANSAS LEE FRICKEY
K952683 04/01/1997 APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE WHOLESALE MEDICAL IMPORTS, INC. SUSAN D GOLDSTEIN-FALK
K965233 04/04/1997 SHARPSITE AC XOMED, INC. DAVID TIMLIN
K963801 04/09/1997 PAP BRUSH YOUNG OU BRUSH CO. STEVE KWAK
K964449 04/10/1997 ANCA SCREEN ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K964446 04/10/1997 MYELOPEROXIDASE ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K964448 04/10/1997 PROTEINASE-3 IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY


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