FDA 510(k) Decisions During June, 1980  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K801057 06/17/1980 3M STEAM STERILIZATION INDICATOR 3M COMPANY
K800725 06/04/1980 A-GENT QUANTICHROM THROMBIGEN I ABBOTT LABORATORIES
K800911 06/20/1980 A-GENT THYROZYME UPTAKE INHIBITOR ASSAY ABBOTT LABORATORIES
K801215 06/04/1980 ABCO PEDIATRIC STETHOSCOPE ABCO DEALERS, INC.
K801197 06/30/1980 CO2 LASER ADVANCED BIOMEDICAL INSTRUMENTS
K801252 06/04/1980 NEBULIZER WITH AIR ENTERTAINER & ETC. AIRLIFE, INC.
K801364 06/17/1980 AO STYLET LARYNGOSCOPE MODEL SLS AMERICAN OPTICAL CORP.
K801036 06/04/1980 SURGICAL MASK AMERICAN THRESHOLD INDUSTRIES, INC.
K800838 06/04/1980 ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. ARCO MEDICAL PRODUCTS CO.
K800837 06/30/1980 PROGRAMMABLE BIPOLAR CARDIAC GENERATOR ARCO MEDICAL PRODUCTS CO.
K801241 06/30/1980 UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. ARCO MEDICAL PRODUCTS CO.
K801332 06/20/1980 AMPCO SKIN SCRUB TRAYS ASSOCIATED MEDICAL PRODUCTS CO.
K800940 06/04/1980 AUDIONICS PB MAX HEARING AID AUDIONICS CORP.
K801301 06/20/1980 GOLDEN THERMAL RHINOPLASTY CAST BANDAGE AURIC, INC.
K801343 06/20/1980 B-D FILTER NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K800797 06/20/1980 MACRO-VUE RUBELLA CARD TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K801240 06/04/1980 BUILT-IN TEMPERATURE MONITORING BENTLEY LABORATORIES, INC.
K801147 06/04/1980 PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 BENTLEY LABORATORIES, INC.
K800366 06/17/1980 SOLARIUM, MODEL 6040A BLENDETTE INTL. LTD.
K800779 06/04/1980 OMNITON MT80-A BODY HEARING AID BOSCH HEARING INSTRUMENTS, INC.
K800845 06/17/1980 BRONZAGE TANNING SYSTEM BRONZAGE RAPIDE
K801311 06/17/1980 BURRON MULTI-AD SYRINGE CAP BURRON MEDICAL PRODUCTS, INC.
K801008 06/02/1980 MULTI-AD FLUID DISPENSING PUMP MP-3000 BURRON MEDICAL PRODUCTS, INC.
K801200 06/04/1980 SAMPLING MANIFOLD H530 C.R. BARD, INC.
K801105 06/09/1980 THYROXINE RADIOIMMUNOASSAY KIT CALBIOCHEM-BEHRING CORP.
K801123 06/09/1980 TRIIODOTHYRONINE RADIOIMMUN. SYSTEM CALBIOCHEM-BEHRING CORP.
K801224 06/26/1980 CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE INSTRUMENTS, INC.
K801122 06/30/1980 MICROTHIN-D1 (MOD. 0620) CARDIAC PACEMAKERS, INC.
K801121 06/30/1980 MICROTHIN-P1 (MOD. 0622) CARDIAC PACEMAKERS, INC.
K801043 06/20/1980 E-VAX CHEST DRAINAGE SYSTEM CARDIO SURGICAL CONCEPTS, INC.
K801221 06/09/1980 THORA-DRAIN III PLASTIC DRAINAGE SYSTEM CHESEBROUGH-POND'S U.S.A. CO.
K801199 06/04/1980 VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX CHESEBROUGH-POND'S U.S.A. CO.
K801367 06/20/1980 MODEL 336B HEARING AID COMMUNICATIONS, INC.
K801187 06/09/1980 CONPHAR "CHECKMATE" SPHYGMOMANOMETER CONPHAR, INC.
K801189 06/04/1980 CONPHAR "SUPERTONE" STETHOSCOPE CONPHAR, INC.
K801185 06/04/1980 CONPHAR BOWLS STETHOSCOPE CONPHAR, INC.
K801186 06/09/1980 CONPHAR DELUXE ANEROID SPHYGMOMANOMETER CONPHAR, INC.
K801188 06/09/1980 CONPHAR DESK TOP MERCURY SPHYGMOMAN CONPHAR, INC.
K801183 06/04/1980 CONPHAR DUAL HEAD STETHOSCOPE CONPHAR, INC.
K801184 06/04/1980 CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE CONPHAR, INC.
K801182 06/04/1980 CONPHAR WALL MODEL MERCURY SPHYGMOMAN. CONPHAR, INC.
K801312 06/17/1980 THE PROTECTORS COOPER MEDICAL DEVICES CORP.
K800795 06/30/1980 PERMANENT & TEMP. PACEMAKER ELECTRODE DAIG CORP.
K801225 06/17/1980 DEN-MAT POLISHING PASTE DEN-MAT CORP.
K801009 06/04/1980 HOWMEDICA WHITE C&B ALLOY DENTAL LABORATORY PRODUCTS DIV.
K801166 06/26/1980 PET-SCOPE II MODEL DIS-1611 DIAGNOSTIC INFORMATION, INC.
K801042 06/26/1980 SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K801094 06/09/1980 SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K800989 06/02/1980 DYNAWASHER II DYNATECH LABORATORIES, INC.
K801276 06/20/1980 DUPONT PREP APPLI. FOR PHENOBARBITAL, E.I. DUPONT DE NEMOURS & CO., INC.
K801209 06/26/1980 KODAK MEDICAL X-RAY DEVELOPER & REPLEN. EASTMAN KODAK COMPANY
K801124 06/17/1980 NYLON LIGATING CLIP ETHICON, INC.
K801374 06/26/1980 PROXIMATE (TMD) TISSUE MEASURING DEVICE ETHICON, INC.
K801154 06/20/1980 PROXIMATE*(ILS) DISP. INTRALUMINAL STAP. ETHICON, INC.
K801144 06/09/1980 ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS ETHOX CORP.
K801045 06/30/1980 GF120H DIALYZER GAMBRO, INC.
K801136 06/20/1980 D300 DOME GICS PHARMACEUTICALS
K801322 06/30/1980 MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS GRAPHIC CONTROLS CORP.
K801321 06/30/1980 PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE GRAPHIC CONTROLS CORP.
K800877 06/17/1980 ANESTHESIA EXTENSION TUBES HARVARD LABORATORIES
K800879 06/17/1980 CLEAR PLASTIC CONNECTING TUBES HARVARD LABORATORIES
K800878 06/17/1980 SECONDARY I.V. TUBING SETS HARVARD LABORATORIES
K800565 06/26/1980 HESSLER COLON THERAPY DEVICE HESSLER MFG. CO.
K801244 06/20/1980 ROCHE HCG STANDARDS HOFFMANN-LA ROCHE, INC.
K801088 06/17/1980 F.R.C. APPARATUS HOGAN/COLOGNE ENT.
K801149 06/30/1980 BEL O SOL UVA SUNLAMP DEVICE HOPEFUL SUNLAMP CORP.
K801313 06/09/1980 COMPRESSION MOLDING OF UHMWPE HOWMEDICA CORP.
K800908 06/02/1980 CAPIK-CANDIDA ALBICANS IDENT. KIT. IMMUNO-MYCOLOGICS, INC.
K801382 06/26/1980 DISPOSABLE SURGICAL HEAD SUPPORT INNOVATIVE SURGICAL PRODUCTS INC.
K801261 06/09/1980 DISPOSABLE COUPLING ADAPTOR INTEC MEDICAL, INC.
K801260 06/04/1980 DISPOSABLE PRESSURE LINE ADAPTOR INTEC MEDICAL, INC.
K801040 06/30/1980 GE LEAD ADAPTER, MODEL 345-01 INTERMEDICS, INC.
K792300 06/04/1980 LIFELINE TLE (TRAEBECULAR LODGING ELEC INTERMEDICS, INC.
K792301 06/04/1980 LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL INTERMEDICS, INC.
K801308 06/20/1980 FIAX TEST KIT FOR TOBRAMYCIN QUANTITA INTL. DIAGNOSTIC TECHNOLOGY
K801363 06/30/1980 COMPLEMENT C3 NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801361 06/30/1980 COMPLEMENT C4 NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801283 06/30/1980 J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY J.T. BAKER CHEMICAL CO.
K801282 06/30/1980 J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA J.T. BAKER CHEMICAL CO.
K801281 06/20/1980 J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI J.T. BAKER CHEMICAL CO.
K801090 06/09/1980 J.T. BAKER LSA 290 PIPETTER/DILUTER J.T. BAKER CHEMICAL CO.
K801091 06/09/1980 K 750 COMPUTER/DATA PROCESSOR J.T. BAKER CHEMICAL CO.
K801304 06/17/1980 CAMLOC SYRINGE BIOPSY KIT JOHANNAH MEDICAL SERVICES, INC.
K801256 06/04/1980 NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY KLEEN TEST PRODUCTS
K801258 06/04/1980 NEEDLE COUNTER-SURE COUNT/10 COUNT KLEEN TEST PRODUCTS
K801259 06/09/1980 NEEDLE COUNTER-SURE COUNT/100 COUNT KLEEN TEST PRODUCTS
K801257 06/04/1980 NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. KLEEN TEST PRODUCTS
K800822 06/17/1980 CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE KLI
K801289 06/30/1980 LEECO GLYCO-HEMOGLOBIN DIAG. TEST KIT LEECO DIAGNOSTICS, INC.
K800890 06/20/1980 LINEBERGER EXTERNAL MALE CATHETER LINEBERGER EXTERNAL CATHETER CO.
K800789 06/30/1980 RUBELLA BIO-BEAD TITRATION KIT LITTON BIONETICS
K800830 06/30/1980 SIEMENS-ELECTROGERATE GMBH MICRO-INHALER MACBETH SALES CORP.
K801062 06/04/1980 BEHIND-THE-EAR HEARING AID SERIES G MAICO HEARING INSTRUMENTS, INC.
K801125 06/09/1980 SPAC T3 RIA TEST KIT MALLINCKRODT CRITICAL CARE
K800843 06/17/1980 MEDEFIZZ A & MEDEFIZZ B MEDEFIELD PTY. LTD.
K800840 06/17/1980 MEDEFOAM-2 MEDEFIELD PTY. LTD.
K801323 06/26/1980 HI-TEMP SURGICAL CAUTERY MEDICAL PRODUCTS DEVELOPMENT, INC.
K801078 06/04/1980 PERFECTEMP OPHTHALMIC CAUTERY MEDICAL PRODUCTS DEVELOPMENT, INC.
K801250 06/17/1980 HYDRA TRED DC MEDICHANICS, INC.
K800069 06/26/1980 MEDTRONIC MODELS 5966/5967, ETC. MEDTRONIC VASCULAR
K801044 06/02/1980 AMES GLUCOMETER REFLECT. PHOTOMETER MILES LABORATORIES, INC.
K801210 06/17/1980 BIOSTATOR PRINTER/PLOTTER MILES LABORATORIES, INC.
K801101 06/17/1980 ANALOR FOUR-ORAL SURGERY MODEL NARCO MCKESSON CO.
K801102 06/17/1980 COMPALOR-ORAL SURGERY MODEL NARCO MCKESSON CO.
K801049 06/26/1980 V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU NEBULAE PRODUCTIONS
K801245 06/20/1980 ATOMLIGHT (LIQUID SCINTILLATION SOLUTION NEW ENGLAND NUCLEAR
K801264 06/26/1980 NUCLEAR ENTERPRISES "1600"/GAMMA COUNTER NUCLEAR ENT. LTD.
K801263 06/20/1980 NUCLEAR ENTERPRISES "1612" MULTI-WELL NUCLEAR ENT. LTD.
K801235 06/20/1980 REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN OKI SHIKS USA LTD.
K801237 06/09/1980 REIGNING CROWN-BRIDGE/POLYCARB. RESIN OKI SHIKS USA LTD.
K801234 06/09/1980 REIGNING DENTURE MADE OF POLYCARB. RESIN OKI SHIKS USA LTD.
K801159 06/20/1980 STREPTO-SEC TM ORGANON, INC.
K801436 06/26/1980 ORTHOPEDIC LOWER EXTREMITY SUSPENSION ORTHOPEDIC SYSTEMS, INC.
K801254 06/09/1980 PENLON I.D.P. PRESSSURE FAILURE ALARM PENLON, INC.
K801255 06/04/1980 PENLON JUMBO CARBON DIOXIDE ABSORBER PENLON, INC.
K801274 06/09/1980 S.S. WHITE-PENNWALT PRELUDE PIT SEALANT PENNWALT CORP.
K801223 06/09/1980 PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A PENTAX PRECISION INSTRUMENT CORP.
K801146 06/04/1980 SAMPLING KIT PHARMASEAL LABORATORIES
K801271 06/09/1980 MODEL 4900 OFF-LINE PREPARATION SYSTEM PM AMERICA, INC.
K801022 06/17/1980 ULTRA-CHEK PACEMAKER MONITOR POWERS MEDICAL SYSTMES
K800987 06/02/1980 MUELLER HINTON AGAR QUALITY ASSURANCE LABORATORY, INC.
K800986 06/02/1980 TRYPTICASE SOY AGAR W5% SHEEP BLOOD QUALITY ASSURANCE LABORATORY, INC.
K801129 06/30/1980 QUICKTAN BOOTH QUICKTAN MFG.
K801226 06/20/1980 TRIGLYCERIDES FOR SMA AND AAII REAGENTS APPLICATIONS, INC.
K800904 06/04/1980 TONOTEST BLOOD PRESSURE MONITOR RETLIF, INC.
K801242 06/20/1980 COBAS REAGENT FOR ALKALINE PHOSPHATASE ROCHE ANALYTICAL INSTRUMENTS, INC.
K801119 06/09/1980 COBAS REAGENT FOR ALT (GPT) ROCHE ANALYTICAL INSTRUMENTS, INC.
K801118 06/20/1980 COBAS REAGENT FOR AST (SGOT) ROCHE ANALYTICAL INSTRUMENTS, INC.
K801116 06/17/1980 COBAS REAGENT FOR BUN ROCHE ANALYTICAL INSTRUMENTS, INC.
K801296 06/30/1980 COBAS REAGENT FOR CHOLESTEROL ROCHE ANALYTICAL INSTRUMENTS, INC.
K801297 06/30/1980 COBAS REAGENT FOR GLUCOSE RAPID ROCHE ANALYTICAL INSTRUMENTS, INC.
K801243 06/26/1980 COBAS REAGENTS FOR URIC ACID ROCHE ANALYTICAL INSTRUMENTS, INC.
K801117 06/09/1980 COBAS TOTAL BILIRUBIN REAGENT & DILUENT ROCHE ANALYTICAL INSTRUMENTS, INC.
K800946 06/20/1980 URINARY CATHETER SAMPLING KIT SAGE PRODUCTS, INC.
K801145 06/09/1980 SMI MULTI-TUBE VORTEXER SCIENTIFIC MANUFACTURING INDUSTRIES
K800902 06/09/1980 BUN-COLOR 2, BLOOD UREA NITROGEN TEST SCLAVO, INC.
K801372 06/26/1980 ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR SHERWOOD MEDICAL CO.
K801371 06/26/1980 ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. SHERWOOD MEDICAL CO.
K801222 06/26/1980 REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER SIMMLER, INC.
K801060 06/04/1980 HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE SMITH KLINE DIAGNOSTICS, INC.
K801014 06/20/1980 STANBIO ACETAMINOPHEN TEST SET #0850 STANBIO LABORATORY
K801096 06/09/1980 PERKIN ELMER MODEL 91 AMYLASE REAGENT STAT ENGINEERING
K801195 06/09/1980 DERMALEX OR NATRAWOOL SKIN PRESSURE PROT STOCK WILD & CO.
K801232 06/17/1980 JACKSON LACRIMAL INTUBATION SET STORZ INSTRUMENT CO.
K800744 06/04/1980 SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1 SUN IND., INC.
K800592 06/04/1980 SUN SCENE TAN BOOTH SUN SCENE INTERNATIONAL, INC.
K801074 06/17/1980 STRAITH NASAL IMPLANT SURGICAL TECHNOLOGY LABORATORIES, INC.
K801072 06/17/1980 STRAITH NASAL SPLINT SURGICAL TECHNOLOGY LABORATORIES, INC.
K801309 06/20/1980 RITTER STERILIZER SYBRON CORP.
K801288 06/30/1980 EMIT AAII THYROXINE ASSAY SYVA CO.
K801287 06/30/1980 EMIT AAII THYROXINE CALIBRATORS SYVA CO.
K801204 06/09/1980 EMIT DISOPYRAMIDE ASSAY SYVA CO.
K801205 06/09/1980 EMIT DISOPYRAMIDE CONTROL SYVA CO.
K801207 06/20/1980 EMIT VALPROIC ACID ASSAY SYVA CO.
K801206 06/17/1980 EMIT VALPROIC ACID CONTROL SYVA CO.
K801017 06/17/1980 TANIT COMMERCIAL SUNTAN BOOTH TANIT, INC.
K800950 06/04/1980 TANIT HOME SUNTANNING UNIT TANIT, INC.
K801203 06/09/1980 CORTISOL RADIOIMMUNOASSAY KIT TECHNIA DIAGNOSTICS LTD.
K801202 06/20/1980 DIGOXIN RADIOIMMUNOASSAY KIT TECHNIA DIAGNOSTICS LTD.
K801056 06/04/1980 "EDP 1200" ULTRASONIC B-SCANNER TECHNICARE CORP.
K801155 06/09/1980 TECHNICON H6000 HEMATOLOGY SYSTEM TECHNICON INSTRUMENTS CORP.
K801272 06/17/1980 TECNOL QUICK RELEASE LIMB HOLDER TECNOL NEW JERSEY WOUND CARE, INC.
K801293 06/17/1980 ACOUSTIC IMPEDANCE METER, MODEL TA-4D TELEDYNE AVIONICS DIV. OF TELEDYNE
K801325 06/30/1980 CLINICAL AUDIOMETER MODEL TA-200 TELEDYNE AVIONICS DIV. OF TELEDYNE
K801393 06/30/1980 AIR ASPIRATOR NEEDLE TEXAS MEDICAL PRODUCTS, INC.
K801398 06/30/1980 AORTIC AND FEMORAL PERFUSION CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801394 06/30/1980 CARDIOPULMONARY BYPASS PUMP TUBING TEXAS MEDICAL PRODUCTS, INC.
K801401 06/30/1980 CARDIOPULMONARY BYPASS TUBING TEXAS MEDICAL PRODUCTS, INC.
K801399 06/30/1980 CORONARY PERFUSION CONNECTOR PLUG TEXAS MEDICAL PRODUCTS, INC.
K801404 06/30/1980 DISPOSABLE PARALLEL "Y" CONNECTORS TEXAS MEDICAL PRODUCTS, INC.
K801405 06/30/1980 DISPOSABLE PERFUSION CONNECTORS TEXAS MEDICAL PRODUCTS, INC.
K801403 06/30/1980 DISPOSABLE PERFUSION SET TEXAS MEDICAL PRODUCTS, INC.
K801400 06/30/1980 DISPOSABLE SUCKER SYSTEM TEXAS MEDICAL PRODUCTS, INC.
K801392 06/30/1980 DISPOSABLE SUMP SETS TEXAS MEDICAL PRODUCTS, INC.
K801402 06/30/1980 QUICKIE PRIME CARDIOP. BYPASS PERF. INTR TEXAS MEDICAL PRODUCTS, INC.
K801396 06/30/1980 SAPHENOUS VEIN CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801395 06/30/1980 VASCULAR CLAMP TEXAS MEDICAL PRODUCTS, INC.
K801397 06/30/1980 VENA CAVA CANNULAE TEXAS MEDICAL PRODUCTS, INC.
K801329 06/09/1980 ANSPACH INSTRUMENT CADDY THE ANSPACH EFFORT, INC.
K801330 06/26/1980 ANSPACH LEG SUPPORT THE ANSPACH EFFORT, INC.
K801326 06/26/1980 ANSPACH OPERATING TABLE SUPPORT/SPINAL THE ANSPACH EFFORT, INC.
K801328 06/09/1980 THE EQUALIZER THE ANSPACH EFFORT, INC.
K801327 06/09/1980 THE EXTRACTOR I TM THE ANSPACH EFFORT, INC.
K801148 06/09/1980 HEMOGASTAT THERAPAC, INC.
K801053 06/04/1980 PULSED GALVANIC STIMULATOR, 450-DYNAMAX U.S. MEDICAL CORP.
K801290 06/30/1980 ALIZARIN SULFONATE, CALCIUM UNION CARBIDE CORP.
K801133 06/17/1980 CENTRIFICHEM HDL CHOLESTEROL UNION CARBIDE CORP.
K801167 06/09/1980 CENTRIFICHEM SYSTEM 400 UNION CARBIDE CORP.
K801139 06/09/1980 CENTRIFICHEM SYSTEM 500 ANALYZER UNION CARBIDE CORP.
K801230 06/17/1980 HEARING AID, UNITRON MODEL C4-55 UNITRON INDUSTRIES, INC.
K800834 06/30/1980 SER-TEX V.S.S.I., INC.
K801310 06/20/1980 THE MAGTEC SYSTEM VALLEY FORGE SCIENTIFIC CORP.
K801383 06/17/1980 ECA CREAM REFORMULATION VANARAY LABORATORIES, INC.
K801251 06/04/1980 NON-CONDUCTIVE, SINGLE USE FACE MASK #55 VITAL SIGNS, INC.
K801229 06/04/1980 BONDALCAP (CARBOXYLATE) VIVADENT (USA), INC.
K801228 06/04/1980 BONDALCAP (SILICO-PHOSPHATE) VIVADENT (USA), INC.
K801076 06/30/1980 WAKO PHOSPHOLIPIDS TEST WAKO PURE CHEMICAL INDUSTRIES, LTD.
K801353 06/30/1980 PARKE-DAVIS SURGICAL LIGHT WARNER-LAMBERT CO.
K801292 06/20/1980 SURGICAL INSTRUMENTS WILLIAM SKIDMORE & CO., LTD.


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