FDA 510(k) Decisions During August, 1983  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K832206 08/24/1983 SPECTROPHOTOMETER #390 ABBOTT DIAGNOSTICS
K832120 08/12/1983 PROMINJET PUMP ABBOTT LABORATORIES
K832123 08/12/1983 VENIPUNCTURE VALVE ABBOTT LABORATORIES
K832595 08/31/1983 VESSEL DILATOR ABBOTT LABORATORIES
K832329 08/24/1983 STERILE IV SET 4 SIZES ABCO DEALERS, INC.
K832281 08/12/1983 TWO-PLY PAPER FACE FACE MASK ABCO DEALERS, INC.
K831847 08/31/1983 JEJUNOSTOMY KIT ACCU-LINE
K831636 08/24/1983 PERCUTANEOUS INTRODUCER KIT ACCU-LINE
K832277 08/16/1983 ACUFLEX LEVY ACL DRILL GUIDE SYS ACUFEX MICROSURGICAL, INC.
K832302 08/16/1983 MARK I TOTAL KNEE SYS. ARTHROPLASTY ADVANCED BIOSEARCH ASSN.
K832185 08/12/1983 OHIO MODEL 922 SPIROMETER AIRCO/OHIO MEDICAL PRODUCTS
K831657 08/24/1983 ALKA FIRST AID KIT ALKA, INC.
K831867 08/12/1983 PRESSURE MONITORING IV BOTTLE CAP ALTO DEVELOPMENT CORP.
K831966 08/11/1983 CARDIOPLEGIA RESERVOIR-#500926 AMERICAN BENTLEY
K832137 08/12/1983 CONVERTORS FLASH STERILIZING TRAY AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K832003 08/10/1983 AQUEOUS BLOOD GAS CONTROL LEVEL I,II & AMERICAN DADE
K832336 08/31/1983 STRATUS AMIKACIN FLUOROMETRIC AMERICAN DADE
K832445 08/31/1983 STRATUS GENTAMICIN FLUOROMETRIC ENZYM AMERICAN DADE
K832408 08/26/1983 STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM AMERICAN DADE
K832323 08/11/1983 EDSLAB PRESSURE GAUGE AMERICAN EDWARDS LABORATORIES
K831659 08/12/1983 FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE AMERICAN EDWARDS LABORATORIES
K831660 08/08/1983 AMS MALLEABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC.
K832070 08/12/1983 AMRESCO NA/K REAGENT SET AMERICAN RESEARCH PRODUCTS CO.
K832071 08/11/1983 TOTAL CO2 REAGENT SET AMERICAN RESEARCH PRODUCTS CO.
K831086 08/12/1983 CEILING MOUNTED SUPPORT AMSCO CO.
K832186 08/12/1983 HALL DRILL/REAMER AMSCO CO.
K832187 08/12/1983 HALL OSCILLATOR AMSCO CO.
K832188 08/12/1983 HALL RECIPROCATOR AMSCO CO.
K831462 08/12/1983 API UNISCEPT PLUS 140 INOCULATOR ANALYTICAL PRODUCTS, INC.
K831648 08/16/1983 ANCHOR BRAND SURGICAL NEEDLES ANCHOR PRODUCTS CO.
K832135 08/16/1983 A.M.S. TEMP. SCAN 300 ANDON MEDICAL SYSTEMS, INC.
K832296 08/31/1983 S2 POSTERIOR-TIB ANSTEK CORP.
K832295 08/31/1983 S2MEDIAN ANSTEK CORP.
K831775 08/11/1983 UCG-BETA SLIDE MONOCLONAL ARMKEL, LLC.
K832051 08/12/1983 RIM-HAEMOPHILUS 1 & 2 AUSTIN BIOLOGICAL LABORATORIES
K832239 08/12/1983 RIM-HAEMOPHILUS 2 AUSTIN BIOLOGICAL LABORATORIES
K831823 08/12/1983 AXIOM FEEDING GASTRO TUBE AXIOM MEDICAL, INC.
K831870 08/12/1983 ALLERGENETICS FLUORO-FAST READER AXONICS, INC.
K831773 08/16/1983 MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK BCD PRODUCTS, INC.
K832229 08/12/1983 BBL ANAGEL POWDER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K832377 08/12/1983 BIOCUFF INFUSION BAG PRESSOR BIO-MEDICAL INSTRUMENTS LTD.
K832175 08/16/1983 DIGILAB 350 THE KRAKAU PERIMETER BIO-RAD
K831053 08/08/1983 QUANTIGEN T & B CELL ASSAY BIO-RAD
K831760 08/08/1983 LEGIONELLA IFA KIT I BIONETIC LABORATORY PRODUCTS
K832023 08/31/1983 EMBOLECTOMY CATHETER BIONOMY, INC.
K831840 08/12/1983 FEEDING TUBE PLACEMENT STYLET BIOSEARCH MEDICAL PRODUCTS, INC.
K830340 08/16/1983 FITKIT I CHECKUP KIT BODITESTOR
K832158 08/16/1983 CHOLESTEROL HIGH PERFORMANCE-K BOEHRINGER MANNHEIM CORP.
K832251 08/24/1983 PRECISET CHOLESTEROL HIGH PERFORM BOEHRINGER MANNHEIM CORP.
K832031 08/11/1983 ANTI-N DNA ANTIBODY TEST KIT BREIT LABORATORIES, INC.
K832064 08/08/1983 VENOUS CATHETER CARDIO SEARCH, INC.
K832337 08/31/1983 AUTO-TENS MODEL V CBC CORP.
K831132 08/08/1983 COMPUDIAL/KP-1 COMPUTER DIALYSIS SYSTEMS, INC.
K832501 08/31/1983 ENEMA TUBE CONE INSTRUMENTS, INC.
K832299 08/26/1983 VISI-FLOW IRRIGATOR CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
K832052 08/08/1983 MODEL 327T UNIPOLAR CARDIAC PULSE GEN COOK PACEMAKER CORP.
K832255 08/12/1983 MODEL F UNIPOLAR ENDOCARDIAL LEAD- COOK PACEMAKER CORP.
K832245 08/12/1983 UNIPOLAR-E ENDOCARDIAL TINED LEAD COOK PACEMAKER CORP.
K832178 08/12/1983 AMPLATZ HEPARIN COATED CATHETER COOK, INC.
K832074 08/01/1983 CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA COOPERVISION, INC.
K832142 08/01/1983 DICON GLAUCOMA DIAG. CENTER 2000 SERIES COOPERVISION, INC.
K832073 08/12/1983 ELECTRIC INSTRUMENT TABLE COOPERVISION, INC.
K832085 08/16/1983 LENSOMETER COOPERVISION, INC.
K832353 08/31/1983 CORNING'S MAGIC T3(125I) RADIOIMMUNO- CORNING MEDICAL & SCIENTIFIC
K831613 08/11/1983 MAGIC TM 125I T3 UPTAKE RADIOASSAY CORNING MEDICAL & SCIENTIFIC
K832167 08/16/1983 CORPAK VTR 300 ENTERNAL PUMP CORPAK CO.
K831566 08/12/1983 CUI MAMMARY PROTHESIS SIZER COX-UPHUFF INTL.
K831761 08/12/1983 SIMPLICITY PLUS CRITIKON COMPANY,LLC
K831964 08/11/1983 CMS 2000 SERIES TPN KITS CURRIE MEDICAL SPECIALTIES, INC.
K832237 08/16/1983 ORTHOPEDIC CASTING TAPE MAXCAST CUTTER LABORATORIES, INC.
K831983 08/08/1983 DATA-ZYME URIC ACID PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K831689 08/11/1983 EMPTY DIALYSATE CONTAINER DELMED, INC.
K832291 08/31/1983 AUTO-TACH DENTSPLY INTL.
K832320 08/31/1983 PRISMA III DENTSPLY INTL.
K832163 08/12/1983 SOPHEIA DIGOXIN EIA KIT DIAGNOSTIC PRODUCTS CORP.
K831496 08/08/1983 ALLERGEN IMMUNOSORBENTS IP SPECIFIC E DIAGNOSTIC REAGENT TECH.
K832154 08/16/1983 DHEA-SULFATE I RIA KIT DIAGNOSTIC SYSTEMS LABORATORIES, INC.
K832117 08/08/1983 IMMULON SUBSTRATE REMOVAWELL STRIPS DYNATECH CORP.
K830756 08/12/1983 GONOCHEK PANEL E-Y LABORATORIES, INC.
K831501 08/26/1983 TACTIL EAR EAR THREE SYSTEMS
K832304 08/31/1983 BRAEGEN III 10-CHANNEL TRANSMITTER- ELECTRO-BIO-MEDICAL SERVICES, INC.
K831945 08/12/1983 ELECATH BALTHERM TLC THERMAL DILUTION ELECTRO-CATHETER CORP.
K831924 08/11/1983 ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS ELECTRO-NUCLEONICS LABORATORIES, INC.
K830992 08/12/1983 XCEL MODEL XE-1 ELECTROCAINE MEDICAL SYSTEM
K831113 08/12/1983 EPCOM EMS-310 INTRAPARTUM MONITOR EPCOM MEDICAL SYSTEMS, INC.
K831115 08/12/1983 EPCOM EMS-320 REMOTE MONITORSCOPE EPCOM MEDICAL SYSTEMS, INC.
K831114 08/12/1983 EPCOM EMS-330 FREEDOM I TELEDOP OBSTET EPCOM MEDICAL SYSTEMS, INC.
K831000 08/08/1983 MEDION MI-200 IONTOPHORETIC MEDICATOR ETHERINGTON INDUSTRIES
K830863 08/31/1983 HANCOCK PERICARDIAL PATCH EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K831029 08/26/1983 HEMOPERFUSION SYSTEM TP-400 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K831095 08/31/1983 ROYALE II FACTOR, II, INC.
K832122 08/12/1983 ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED FLUIDOTHERAPY CORP.
K831821 08/08/1983 PNEUMATIC/ELECTRIC/HYDRAULIC BED G.W. HEALTHCARE, INC.
K831995 08/08/1983 TRENDO-SCOPE GABRIEL ENT.
K832473 08/16/1983 GAMMA SLIDE TEST FOR PREGNANCY GAMMA BIOLOGICALS, INC.
K831852 08/11/1983 FETAL MONITOR #115 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K823225 08/12/1983 GELIPERM GRANULES GEISTLICH-PHARMA
K832268 08/12/1983 RABBIT ANTI-HUMAN ANTITHROMBIN III GELCO DIAGNOSTICS, INC.
K831845 08/24/1983 PER-Q-CATH TRAY GESCO INTL., INC.
K832094 08/11/1983 BILIRUBIN CALIBRATORS & CONTROL GILFORD DIAGNOSTICS
K832396 08/31/1983 CENTRAL VENOUS ACCESS CATHETER CVAC GISH BIOMEDICAL, INC.
K822073 08/12/1983 GELIPERM DRY HAMEL, PARK, MCCABE & SAUNDERS
K822058 08/12/1983 GELIPERM TRANSPARENT GEL-FILM DRESSING HAMEL, PARK, MCCABE & SAUNDERS
K832201 08/16/1983 CHROM-PREP HAMILTON CO.
K832199 08/16/1983 HC40/HC75 CATION EXCHANGE RESIN HAMILTON CO.
K832198 08/12/1983 HC40/HC75 PREPACKED COLUMS HAMILTON CO.
K832204 08/24/1983 MICROLAB P HAMILTON CO.
K832203 08/08/1983 MULTI-TITER DISPENSER HAMILTON CO.
K832202 08/24/1983 PB 600 REPEATING DISPENSER HAMILTON CO.
K832205 08/24/1983 PRECISION LIQUID DISPENSER HAMILTON CO.
K832200 08/16/1983 PRP-1 REVERSED PHASE COLUMNS FOR HPLC HAMILTON CO.
K832197 08/12/1983 PRP-1 REVERSED PHASE RESIN HAMILTON CO.
K832477 08/16/1983 OCULOPRESSOR HANS GEVDER
K831129 08/12/1983 HEARCO C HEAR CO., INC.
K831994 08/08/1983 BIOCHECK POSITIVE URINE CONTROL HELENA LABORATORIES
K832087 08/24/1983 TITAN GEL GLYCO-HEME SYSTEM HELENA LABORATORIES
K830914 08/12/1983 EXTERNAL VALVE FUNCTION BLOCK HONEYWELL, INC.
K831373 08/26/1983 P.C.A. HIP SYSTEM HOWMEDICA CORP.
K831143 08/16/1983 P.C.A. UNICOMPARTMENTAL KNEE PROSTHES HOWMEDICA CORP.
K832397 08/31/1983 HYBRITECH 405-500 NM FILTER MODULE HYBRITECH, INC.
K832364 08/26/1983 PHOTON IMMUNOASSAY ANALYZER HYBRITECH, INC.
K832139 08/12/1983 TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY HYBRITECH, INC.
K831794 08/16/1983 SETS & TRAYS I M, INC.
K831796 08/08/1983 URINE BAG SYSTEM I M, INC.
K831935 08/08/1983 ENTERNAL PUMP & ADMIN. SET 430 IMED CORP.
K831486 08/12/1983 SC-603 TWIN VALVE INSTRUMENTATION INDUSTRIES, INC.
K832409 08/12/1983 LIFELINE PACING LEADS #471-07 &09 INTERMEDICS, INC.
K832054 08/26/1983 FIAX CRP TEST KIT INTL. DIAGNOSTIC TECHNOLOGY
K832383 08/31/1983 IDT ANA STIQ ASSAY INTL. DIAGNOSTIC TECHNOLOGY
K832321 08/12/1983 ACCES. HEAD CONTROL-POWERED CHEELCHAIR INTL. MEDICAL EQUIPMENT CORP.
K832325 08/12/1983 BASE ONLY, POWER WHEELCHAIR INTL. MEDICAL EQUIPMENT CORP.
K832322 08/12/1983 BASE ONLY, TORONTO CHAIR INTL. MEDICAL EQUIPMENT CORP.
K832062 08/31/1983 ADAPTIC*FAST SET DENTAL RESTORATIVE JOHNSON & JOHNSON PROFESSIONALS, INC.
K832382 08/12/1983 CAREFREE * PANTY SHIELDS-REG/DEOR JOHNSON & JOHNSON PROFESSIONALS, INC.
K832061 08/31/1983 LIGHT CURING BONDING AGENT JOHNSON & JOHNSON PROFESSIONALS, INC.
K832114 08/26/1983 COATEST FACTOR X KABIVITRUM, INC.
K832340 08/12/1983 OPERATING ROOM TABLES HYDRAULIC KAMIYA TSUSAN KAISHA, LTD.
K832010 08/01/1983 BRONCHO-FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.
K832063 08/26/1983 ROBIN CORDLESS HANDPIECE KAYCOR INTL., LTD.
K832437 08/16/1983 MEDIC LUX DIAGNOSTIC SETS KEELER INSTRUMENTS, INC.
K831961 08/11/1983 IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN KENT LABORATORIES, INC.
K832037 08/16/1983 INSPIREASE KEY PHARMACEUTICALS, INC. ALENDER GIAQUINTO
K831986 08/08/1983 METAL-BACKED ACE TABULAR CUP KIRSCHNER MEDICAL CORP.
K831733 08/24/1983 TEMPERATURE MODULE 242-100 KONTRON INSTRUMENTS, INC.
K832103 08/12/1983 BLOOD TUBING SET LEE MEDICAL INTL., INC.
K832143 08/26/1983 MARK III OXYGEN WALKER SYS. RESERVOIR LINDE DIV. UNION CARBIDE CORP.
K831343 08/08/1983 CMV RQ BIO-ENZABEAD KIT LITTON BIONETICS
K832042 08/12/1983 LME TEMP. MONITOR LITTON MEDICAL ELECTRONICS
K830797 08/24/1983 IMMOBILINE SYSTEM LKB 1819 LKB INSTRUMENTS, INC.
K831567 08/10/1983 FOLEY-TEMP MALLINCKRODT CRITICAL CARE
K831063 08/24/1983 BUTTON INFUSER MARKWELL MEDICAL INSTITUTE, INC.
K831793 08/12/1983 AQUALIZER MOUTHPIECE MARTIN D. LERMAN
K832124 08/12/1983 CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI MED-WEST, INC.
K831661 08/25/1983 DISPOSABLE SCISSORS MEDCARE PRODUCTS
K832210 08/24/1983 GAMMA PHOTON GAMMA COUNTER MEDICAL & SCIENTIFIC DESIGNS, INC.
K832209 08/24/1983 KINETI COUNT 24 GAMMA COUNTER MEDICAL & SCIENTIFIC DESIGNS, INC.
K831857 08/11/1983 SURGITEK PERCUTANEOUS ARNEGRADE SILITEK MEDICAL ENGINEERING CORP.
K832128 08/08/1983 SELF-SEAL STERILIZATION POUCHES MEDICAL INDUSTRIES PACKAGING, INC.
K831584 08/12/1983 BAILEY ASPIRATOR/IRRIGATOR MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
K830754 08/12/1983 BLOOD PRESSURE MONITORING KITS,WALRUS MEDICAL PARAMETERS, INC.
K832398 08/24/1983 DYNACOR CONNECTING TUBING MEDLINE INDUSTRIES, INC.
K832059 08/24/1983 IONOPHORELIC SWEAT STIM. CHLORIDE- MEDTRONIC VASCULAR
K832238 08/31/1983 NEUROMOD COMFORT WAVE #7721 DUAL- MEDTRONIC VASCULAR
K831746 08/11/1983 PISCES #3487 EPIDURAL LEAD FOR SPINAL MEDTRONIC VASCULAR
K831599 08/11/1983 MERITEC-STREP GROUP A BETA-HEMOLYTIC MERIDIAN DIAGNOSTICS, INC.
K832046 08/11/1983 SERALYZER MULTICOMPONENT CALIBRATORS MILES LABORATORIES, INC.
K831989 08/08/1983 VISIDEX II REAGENT STRIPS MILES LABORATORIES, INC.
K832161 08/01/1983 AMBULIZER MODEL MC-5 MOBILIZER MEDICAL PRODUCTS, INC.
K831622 08/11/1983 MORHEL CLOSED URINARY DRAINAGE SET MORHEL MEXICANA
K832343 08/12/1983 DERMALAND DURAL HOOKS NATIONAL FABTRONIX, INC.
K832127 08/12/1983 NAUTILUS MONOPLACE HYPERBARIC UNIT NAUTILUS ENVIRONMEDICAL SYSTEMS, INC.
K832331 08/16/1983 US-1000 ULTRASONIC IMAGING SYSTEM NIDEK, INC.
K832301 08/31/1983 DIRECT BONDED BRACKET REMOVER NORTHWEST ORTHOPEDICS
K831698 08/11/1983 DISPOSABLE PRESSURE TRANSDUCER#14004195 NORTON PERFORMANCE PLASTICS CORP.
K832224 08/12/1983 NOVA LIFT CHAIR NOVA HEALTH CONCEPTS, INC.
K831578 08/12/1983 PHYSIOLOGICAL MONITOR #902 NOVAMETRIX MEDICAL SYSTEMS, INC.
K832002 08/08/1983 NML-5010/5020 MULTI-DETECTOR SYSTEM NUCLEAR MEDICAL LABORATORIES, INC.
K832182 08/12/1983 LYSING REAGENT OMEGA MEDICAL DIAGNOSTICS
K831897 08/12/1983 BETA I PROGRAMMABLE INFUSION PUMP ORANGE MEDICAL INSTRUMENTS, INC.
K831644 08/01/1983 PIPETTE 12 CHANNEL ORGANON TEKNIKA CORP.
K831641 08/11/1983 READER MICROELISA SYSTEM ORGANON TEKNIKA CORP.
K831640 08/08/1983 WASHER 6000 MICRO-C LISA SYSTEM ORGANON TEKNIKA CORP.
K832225 08/12/1983 ORTHO ABNORMAL COAGULATION LEVEL I/II ORTHO DIAGNOSTIC SYSTEMS, INC.
K831670 08/24/1983 ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO ORTHO DIAGNOSTIC SYSTEMS, INC.
K832494 08/16/1983 SCOLIOMETER ORTHOPEDIC SYSTEMS, INC.
K832306 08/24/1983 BILE AESCULIN DISCS OXOID U.S.A., INC.
K832307 08/26/1983 ONPG DISCS OXOID U.S.A., INC.
K832305 08/24/1983 SPS DISCS OXOID U.S.A., INC.
K831282 08/12/1983 BANDAGE COMPRESS PAC-KIT SAFETY EQUIPMENT CO.
K831284 08/12/1983 GAUZE BANDAGE PAC-KIT SAFETY EQUIPMENT CO.
K831281 08/12/1983 GAUZE COMPRESS PAC-KIT SAFETY EQUIPMENT CO.
K831283 08/12/1983 TRIANGLE BANDAGE STERILE PAC-KIT SAFETY EQUIPMENT CO.
K831443 08/12/1983 PACELINE PATIENT TRANSMITTER MODEL 324 PACESETTER SYSTEMS
K832075 08/12/1983 ELECTRONIC BLOOD PRESS. METER-ZH-820P PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA
K831151 08/11/1983 PANASONIC MODEL EW-213 PANASONIC CO. DIV. MATSU ELEC. CORP. AMERICA
K830682 08/11/1983 CARDIVAN BLOOD PRESSURE MONITOR PARAMED TECHNOLOGY, INC.
K830870 08/12/1983 POLYCHACO INDIRECT HEMAGGLUTINATION PARASITIC DISEASE CONSULTANTS
K830869 08/11/1983 POLYCHACO INDIRECT IMMUNOFLUORESCENCE PARASITIC DISEASE CONSULTANTS
K831402 08/08/1983 PRESSURE MONITOR & CONTROL UNIT APC-02A PARKER HANNIFIN CORP.
K821799 08/16/1983 FITKIT I CHECKUP KIT PATTON, BOGGS & BLOW
K832006 08/01/1983 PENTAX FD-34A DUODENOFIBERSCOPE PENTAX PRECISION INSTRUMENT CORP.
K832007 08/11/1983 PENTAX FG-34JA GASTROFIBERSCOPE PENTAX PRECISION INSTRUMENT CORP.
K832080 08/01/1983 PHONIC EAR PE 467R-PE 461T PHONIC EAR, INC.
K832081 08/01/1983 PHONIC EAR PE 845PPC-D PHONIC EAR, INC.
K831837 08/01/1983 CLINOVATIVE II DIAGNOSTIC KIT PIERCE CHEMICAL CO.
K831631 08/12/1983 GASTROSTOMY FEEDING SET PLASCO, INC.
K831116 08/12/1983 INVAC W/VARIOUS MODELS PMT CORP.
K832461 08/16/1983 POLYCORE POLYCORE OPTICAL PTE LTD.
K830716 08/12/1983 CARDIO-ESOPHASCOPE PORTEX, INC.
K831330 08/10/1983 UNIVERSAL CORONARY CANNULA POSSIS MEDICAL, INC.
K831130 08/12/1983 DISPOS. ABODOMINAL RETRACTING PAD PRODUCT DEVELOPMENT CORP.
K831396 08/12/1983 P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
K831526 08/12/1983 URINE TOTAL PROTEIN CONTROL QUANTIMETRIX CORP.
K830541 08/08/1983 INJECTION SEALING CAP 13791 QUINTON, INC.
K832464 08/16/1983 MASSAGE TABLE AAT-100 R & D SYSTEMS, INC.
K831834 08/26/1983 RAICHEM ACID PHASPHATASE REAGENT REAGENTS APPLICATIONS, INC.
K832511 08/31/1983 RECLINING WHEELS RECLINING WHEELS
K831759 08/12/1983 INTRACARDIA SUCKERS RESEARCH INDUSTRIES CORP.
K831769 08/12/1983 VARIOUS CARDIOVASCULAR SURGICAL DEVICE RESEARCH INDUSTRIES CORP.
K832451 08/12/1983 CLEAR-RITE 3 RICHARD-ALLAN MEDICAL IND., INC.
K831976 08/12/1983 POWER OPTIC RITTER CO.
K830292 08/12/1983 BIOELECTRICAL IMPEDANCE ANALYZER #101 RJL SYSTEMS, INC.
K831724 08/12/1983 CHIN (MENTOPLASTY) IMPLANTS S. JACKSON, INC.
K831726 08/11/1983 EYE MUSCLE SLEEVES S. JACKSON, INC.
K831725 08/16/1983 FOIL IN 3 FORMS-NON-STERILE SHEETS S. JACKSON, INC.
K831727 08/12/1983 QUARTER GLOBE CAPS S. JACKSON, INC.
K831723 08/12/1983 SUPRAMID EXTRA SURGICAL MESH S. JACKSON, INC.
K832183 08/24/1983 SANDARE CALCIUM PROCEDURE SANDARE CHEMICAL CO., INC.
K832169 08/16/1983 TOTAL PROTEIN PROCEDURE SANDARE CHEMICAL CO., INC.
K832112 08/31/1983 NO-MIX 30 ORTHODONTIC BONDING SYSTEM SCIENTIFIC PHARMACEUTICALS, INC.
K831381 08/31/1983 RAPID ATRIAL PACER SEAMED CORP.
K831048 08/12/1983 TUFCOTE EPILATION PROBE SERAPIS MEDICAL ELECTRONICS, CO.
K832027 08/08/1983 ARGYLE YANKAVER SUCTION TUBE W/CONTROL SHERWOOD MEDICAL CO.
K832578 08/31/1983 MONOJET SAMPLETTE ADAPTERS SHERWOOD MEDICAL CO.
K830763 08/26/1983 FR ROOT CANAL FILLER SHIZAI CORP.
K832236 08/31/1983 SIGMA PROCEDURE #550 DETERM. BILIRUB SIGMA CHEMICAL CO.
K831824 08/11/1983 DENTAL ELECTRONIC/S.B.R TRADING BU HAND SILVERMAN'S
K832181 08/12/1983 SNO STRIPS STERILE TEARFLOW TEST STRIP SMITH & NEPHEW, INC.
K832126 08/12/1983 MICRO Z DISPOS. SPINAL ANESTH. NEEDLE SMITH & NEPHEW, MPL DIVISION
K831294 08/31/1983 SOLARCRY/TEMPORARY CROWN & BRIDGE MAT SOLAR DENTAL CO., INC.
K831506 08/12/1983 DISP. TRANSDUCER W/MONITORING KIT TRANS SORENSEN RESEARCH
K832146 08/16/1983 TA-400 TEMP. FEEDBACK DEVICE SPECTRAL DATA SYSTEMS
K832140 08/12/1983 CRYOMEDICS 5000 CRYOPROBES SPEMBLY MEDICAL LTD.
K832334 08/12/1983 CRYOMEDICS 5000 CRYOSURGICAL CONSOLE SPEMBLY MEDICAL LTD.
K831963 08/12/1983 CRYOMEDICS NEUROSTAT SPEMBLY MEDICAL LTD.
K831950 08/01/1983 PULSAR #B SINGLE CHANNEL TENS-PULSAR D SPEMBLY MEDICAL LTD.
K832444 08/31/1983 ENZYMATIC TRIGLYCERIDES #2000 STANBIO LABORATORY
K832159 08/16/1983 UNITIZED ENZYMATIC GLUCOSE TEST SET STANBIO LABORATORY
K832011 08/12/1983 AMERI CLEAR STEPHENS SCIENTIFIC
K831874 08/12/1983 LIPASE REAGENT SET STERLING BIOCHEMICAL, INC.
K832174 08/12/1983 GAUZE SPONGE NON-STERILE SUDRECA SURGICAL DRESSINGS, INC.
K832173 08/12/1983 GAUZE SPONGE STERILE SUDRECA SURGICAL DRESSINGS, INC.
K832172 08/12/1983 GAUZE SPONGE X-RAY DETECTABLE- SUDRECA SURGICAL DRESSINGS, INC.
K831975 08/31/1983 LEADING EDGE OPHTHALMIC KNIFE SURGIDEV CORP.
K832034 08/01/1983 EMIT AAD THEOPHYLLINE ASSAY SYVA CO.
K832033 08/01/1983 EMIT AED PHENYTOIN ASSAY SYVA CO.
K832056 08/08/1983 EMIT AMD GENTAMICIN ASSAY SYVA CO.
K832055 08/08/1983 EMIT ASSAY AND TOBRAMYCIN SYVA CO.
K832096 08/08/1983 EMIT CAD QUINIDINE ASSAY FOR USE W/ SYVA CO.
K831978 08/11/1983 EMIT SERUM TRICYCLIC ANTIDEPRESSENT SYVA CO.
K832098 08/12/1983 N-ACETYLPROCAINAMIDE ASSAY FOR COBAS SYVA CO.
K832097 08/11/1983 PHENOBARTIAL ASSAY USE ON COBAS-BIO SYVA CO.
K831800 08/16/1983 TEXAS INTERFACE PRESSURE EVALUATOR-TIPE TEE-KAY APPLIED TECHNOLOGY
K832110 08/12/1983 ELECTRODE LEADS 030-267 & 030-268 TELECTRONICS, INC.
K831771 08/16/1983 IMPLANTABLE PROGRAM. CARDIAC PULSE GEN TELECTRONICS, INC.
K831614 08/12/1983 INSPETOSCOPE TERAYCO INTL., LTD.
K832252 08/26/1983 CLIRANS TAF06 HOLLOW FIBER DIALYZER TERUMO MEDICAL CORP.
K832232 08/08/1983 EPINEED EPIDURAL CATHETER TERUMO MEDICAL CORP.
K832233 08/08/1983 EPINEED EPIDURAL NEEDLE TERUMO MEDICAL CORP.
K831649 08/24/1983 THERMOMIXER S213-PHOTOANALYZER S263 TEXAS INTL. LABORATORIES, INC.
K831387 08/24/1983 HS-100 HEADSPACE SAMPLING ACCESSORY THE PERKIN-ELMER CORP.
K831557 08/24/1983 INTRAOPERATIVE AUTOTRANSFUSION SYS THORATEC LABORATORIES CORP.
K831955 08/11/1983 HR 100T THOUGHT TECHNOLOGY LTD.
K832084 08/16/1983 EVOKED 3500 POTENTIAL SYSTEM TRACOR NORTHERN, INC.
K831668 08/16/1983 CONTINU-FLO SOLUTION ADMINISTRATION TRAVENOL LABORATORIES, S.A.
K832166 08/16/1983 FLO-GARD 8500 MICROINFUSION PUMP TRAVENOL LABORATORIES, S.A.
K831940 08/08/1983 GAMMA STERILIZED CAPILLARY FLOW DIALYZ TRAVENOL LABORATORIES, S.A.
K832165 08/08/1983 IMPROVED SILICATH SILICONE ELASTOMER TRAVENOL LABORATORIES, S.A.
K831350 08/12/1983 IVFLO-HP & IVFIL-HP FILTER TRI-MED, INC.
K831315 08/12/1983 TRILEX TRI-MED, INC.
K831389 08/10/1983 STAT-TRAK LIQUID ELECTROLYTE CONTROL UNITED DIAGNOSTICS, INC.
K831457 08/08/1983 AUTO SUTURE POLY SURGICLIP HEMOSTATIC UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K830741 08/11/1983 PARAMETRIC STERILITY RELEASE OF AUTO UNITED SURGICAL CORP.
K832253 08/31/1983 X-704 UNITEK CORP.
K831883 08/12/1983 HEARING AID UNITRON #UE8-D UNITRON INDUSTRIES, INC.
K832193 08/31/1983 NICE PACK UNIVERSAL MEDICAL INSTRUMENT CORP.
K832008 08/12/1983 INFUTROL 7000 INFUSION PUMP VALLEYLAB, INC.
K832144 08/01/1983 SPLINT WOOD VERMONT WOOD INDUSTRIES, INC.
K832223 08/31/1983 PERIODONTAL IRRIGATOR #7620 VIPONT LABORATORIES, INC.
K832222 08/31/1983 PRO PULSE PERIODONTAL IRRIGATOR 7618 VIPONT LABORATORIES, INC.
K831873 08/12/1983 BONE SCREW W.L. GORE & ASSOCIATES,INC
K830806 08/13/1983 VASCULAR GRAFT/BIFURCATED/FEP-RINGED W.L. GORE & ASSOCIATES,INC
K832004 08/11/1983 WAKO CPK TEST WAKO CHEMICALS, USA, INC.
K831777 08/31/1983 COLLINS DS WARREN E. COLLINS, INC.
K831779 08/26/1983 COLLINS EAGLE II WARREN E. COLLINS, INC.
K831778 08/31/1983 RS-RESIDUAL VOLUME SYSTEM WARREN E. COLLINS, INC.
K831593 08/12/1983 MAXI SHIELDS WEYERHAEUSER CO.
K830656 08/16/1983 AMBULATORY MARK III INFUSION DEVICE WINDSOR MEDICAL, INC.
K837776 08/18/1983 AOR X-RAY ALIGMENT PAD ZIMMER, INC.


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