FDA 510(k) Decisions During March, 1980  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K792050 03/10/1980 3M SMALL VOLUME INFUSTION (SVI) SYSTEM 3M COMPANY
K800485 03/18/1980 VINYL POLYSILOXANE IMPRESSION MATERIAL 3M COMPANY
K800377 03/19/1980 CARDIOPLEGIA DELIVERY SYSTEM 3M HEALTH CARE, SARNS
K791330 03/03/1980 HYSTEROSER A. B. VACUUM EXTRACTOR, INC.
K800416 03/25/1980 ADT DISPOSABLE THIN NEEDLE(SKINNY CHIBA) A.D.T. LAB INDUSTRIES
K800415 03/25/1980 ADT MENGHINI TYPE SOFT TISSUE BIOPSY A.D.T. LAB INDUSTRIES
K800422 03/12/1980 ADT MINI PERITONEAL LAVAGE KIT A.D.T. LAB INDUSTRIES
K800423 03/25/1980 ADT NERVE BLOCK TRAY(DISP.) A.D.T. LAB INDUSTRIES
K800420 03/25/1980 ADT PERCUTANEOUS " "NON-DISP. NEEDLE A.D.T. LAB INDUSTRIES
K800419 03/25/1980 ADT PERCUTANEOUS TRANSHEPATIC DISP. CHOL A.D.T. LAB INDUSTRIES
K800421 03/25/1980 ADT PERITONEAL LAVAGE TRAY (DISP.) A.D.T. LAB INDUSTRIES
K800407 03/12/1980 FERRIS BONE MARROW -NEEDLE-(DISPOSABLE) A.D.T. LAB INDUSTRIES
K800406 03/12/1980 FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE A.D.T. LAB INDUSTRIES
K800413 03/25/1980 FERRIS MODIFIED DISP. IL STERNAL-ILIAC A.D.T. LAB INDUSTRIES
K800294 03/10/1980 0.45% SODIUM CHLORIDE SOL./RESP. THERAPY ABBOTT LABORATORIES
K800295 03/10/1980 0.9% SODIUM CHLORIDE SOL./RESP. THERAPY ABBOTT LABORATORIES
K800137 03/20/1980 PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN ABBOTT LABORATORIES
K800429 03/19/1980 TRYPTIC SOY BROTH W/C02,CYSTEINE & 1% " ABBOTT LABORATORIES
K800427 03/19/1980 TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT ABBOTT LABORATORIES
K800428 03/19/1980 TRYPTIC SOY BROTH W/CYSTEINE AND " " ABBOTT LABORATORIES
K800426 03/19/1980 TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST ABBOTT LABORATORIES
K800013 03/07/1980 FETAL MONITOR MODEL FHM-1 ADVANTAGE MEDICAL SYSTEMS, INC.
K800498 03/25/1980 ADULT ANESTHESIA BREATHING CIRCUITS . . AIRLIFE, INC.
K800499 03/25/1980 PEDIATRIC ANESTHESIA BREATHING CIRCUITS AIRLIFE, INC.
K800327 03/25/1980 MAGNESIUM REAGENT ALTA DIAGNOSTICS, INC.
K800192 03/12/1980 DURALITE LENS AMERICAN OPTICAL CORP.
K800374 03/12/1980 AMERLEX T-3 RIA KIT AMERSHAM CORP.
K800300 03/05/1980 AMERLEX T-4 RIA KIT AMERSHAM CORP.
K800320 03/25/1980 CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA. AMERSHAM CORP.
K800299 03/03/1980 FERRITIN RIA KIT AMERSHAM CORP.
K800370 03/12/1980 CK/LD ISOENZYME CONTROL PROD. #ACS CT101 ANALYTICAL CONTROL SYSTEMS, INC.
K800558 03/25/1980 LIPID CONTROL PRODUCT # ACS LC 101 ANALYTICAL CONTROL SYSTEMS, INC.
K800559 03/25/1980 SERTROL PRODUCT # ACS ST 101 ANALYTICAL CONTROL SYSTEMS, INC.
K800061 03/12/1980 BOND ELUT COLUMNS ANALYTICHEM INTERNATIONAL, INC.
K800326 03/17/1980 ARCOLITH 3021-CARDIAC PULSE GENERATOR ARCO MEDICAL PRODUCTS CO.
K800250 03/25/1980 HMB-200 ASSOCIATED MILLS, INC.
K800303 03/03/1980 ELECTRONIC PERINEOMETER ASSOCIATES IN BIOFEEDBACK
K800489 03/25/1980 LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 ATC MEDICAL TECHNOLOGY, INC.
K800015 03/25/1980 AXIOM VESSEL LOOPS AXIOM MEDICAL, INC.
K800396 03/25/1980 STAT TEMP MODEL 4800 BAESSLER MEDICAL ELECTRONICS,INC.
K800582 03/25/1980 BARNES-HOND HARD CONTACT LENS STOR. CASE BARNES-HIND, INC.
K800436 03/19/1980 T3 SOLID PHASE RADIOIMMUNOASSAY KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K800457 03/20/1980 LIQUID-STAT LIQUID REAGENT BECKMAN INSTRUMENTS, INC.
K792725 03/05/1980 FIXOMULL BEIERSDORF, INC.
K800563 03/25/1980 BLOM-SINGER DUCKBILL VOICE PROSTHESIS BIVONA MEDICAL TECHNOLOGIES
K800315 03/19/1980 DUAL MPC CHARGER BLACK & DECKER(TM)
K800314 03/19/1980 POWER PACK BLACK & DECKER(TM)
K800205 03/19/1980 RIA PHASE DIGOXIN BOEHRINGER MANNHEIM CORP.
K800203 03/19/1980 RIA PHASE T4 BOEHRINGER MANNHEIM CORP.
K800204 03/19/1980 RIA PHASE TBG BOEHRINGER MANNHEIM CORP.
K800437 03/12/1980 SYRINGE TIP CONNECTOR BURRON MEDICAL PRODUCTS, INC.
K800552 03/20/1980 ZEISS DISPOSABLE, STERILE SURGICAL DRAPE CARL ZEISS, INC.
K800328 03/03/1980 NEISSERIA GONORRHOEAE FLUORO-KIT CLINICAL SCIENCES, INC.
K792647 03/17/1980 AUTOSCAN 3 CNR LABS
K800373 03/12/1980 TENDERLIFT COMPETENT DESIGN
K800544 03/20/1980 CORNING TRANSPHOR CORNING MEDICAL & SCIENTIFIC
K800381 03/19/1980 REFRIG. CENTRIFUGE (DRUCKER MODEL) COULTER ELECTRONICS, INC.
K800547 03/25/1980 MEDISTOR III LUNG ANALYZER CYBERMEDIC, INC.
K800296 03/05/1980 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K800571 03/20/1980 DAHLBERG #AZ BEHIND THE EAR HEARING AID DAHLBERG ELECTRONICS, INC.
K800345 03/12/1980 MODEL 795U BEHIND THE EAR HEARING AID DANAVOX, INC.
K800286 03/12/1980 CRITERION II PACING SYSTEM MONITORS DART MEDICAL EQUIPMENT
K800166 03/17/1980 DENTSPLY DENTURE CLEANER DENTSPLY INTL.
K800400 03/12/1980 MAXUM DENTURE RESIN DENTSPLY INTL.
K800494 03/18/1980 NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS DEPUY, INC.
K800398 03/12/1980 PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT DIAGNOSTICA, INC.
K800140 03/03/1980 SILASTIC SCLERAL SPONGE II W/CIRCLING BD DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K800435 03/12/1980 HEMOSTATIC/TUBE OCCLUDING FORCEPS DRAVON MEDICAL, INC.
K800522 03/25/1980 MICRO ELISA AUTO READER DYNATECH LABORATORIES, INC.
K800206 03/03/1980 ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. E.I. DUPONT DE NEMOURS & CO., INC.
K800516 03/19/1980 DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. E.I. DUPONT DE NEMOURS & CO., INC.
K800318 03/10/1980 DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI EDWARD WECK, INC.
K800367 03/10/1980 MICRESURGICAL TRAY, SM.,MED., & LG. EDWARD WECK, INC.
K800368 03/12/1980 OPHTHALMIC FORCEPS EDWARD WECK, INC.
K792441 03/17/1980 CARPENTIER-EDWARDS FLEX. ANNULOPLASTY EDWARDS LABORATORIES
K792602 03/25/1980 SUSI II PACEMAKER SURVEILLANCE MONITOR ELA MEDICAL, INC.
K792635 03/19/1980 ANTIBODY TO RUBELLA VIRUS ELECTRO-NUCLEONICS LABORATORIES, INC.
K800449 03/12/1980 GEMENI IGA ASSAY ELECTRO-NUCLEONICS LABORATORIES, INC.
K800317 03/12/1980 DAVOL EMS ADAPTER, CAT. NO. 13-7664 ELECTROCAINE MEDICAL SYSTEM
K800380 03/17/1980 FES ORTHOSIS MODEL NO. 2000 EMPI
K800458 03/25/1980 ORTHODONTICARTIDE EUROPEAN ORTHODONTIC PRODUCTS
K800445 03/12/1980 EDINBURGH MASKER FOUNDATION FOR FLUENCY, INC.
K800521 03/12/1980 THE LENS OR OMMI-GARD GENTEX CORPORATION
K800372 03/03/1980 SANITARY NAPKINS, MAXI 30'S GIANT EAGLE MARKETS, INC.
K800329 03/03/1980 CAMPYLOBACTER AGAR, CAT. NO. P2536 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K800341 03/12/1980 BUN REAGENT GILFORD DIAGNOSTICS
K800534 03/25/1980 MODEL 52 BUNN DRY AIR SUPPLY GREENE & KELLOGG, INC.
K800491 03/04/1980 GRAPHIC STRESS TELETHERMOMETRY GST LABORATORIES OF CA, INC.
K800238 03/10/1980 MOIRE FRINGE VISOMETER AFTER LOTMAR HAGG-STREIT SERVICE, INC.
K800395 03/17/1980 ARISTOSURG 250 HALMON-LOCREN, INC.
K800548 03/18/1980 SUPERSIL HARRY J. BOSWORTH CO.
K800432 03/25/1980 HELENA RISTOCETIN HELENA LABORATORIES
K800161 03/19/1980 HEPCON/SYSTEM RC-10 HEMOTEC, INC.
K800556 03/25/1980 DIFFERENTIAL REFRACTIVE INDEX DETECTOR HEWLETT-PACKARD CO.
K800364 03/12/1980 ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 HOFFREL INSTRUMENTS, INC.
K800514 03/19/1980 PHENCYCLIDINE DIRECT BLOOD RIA KIT IMMUNALYSIS CORPORATION
K800444 03/05/1980 GOLDEN RETRIEVERS OR SILVER RETRIEVERS INSTRUMENT MAKAR, INC.
K800282 03/05/1980 DATA MANAGEMENT SYSTEM IL MODEL 775 INSTRUMENTATION LABORATORY CO.
K800562 03/25/1980 DISPOSABLE HAND HELD NEBULIZER INTEC MEDICAL, INC.
K792559 03/03/1980 FIAX TEST KIT FOR HERPES SIMPLEX VIRUS INTL. DIAGNOSTIC TECHNOLOGY
K800334 03/03/1980 MARTIN-LEWIS AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K800333 03/03/1980 MODIFIED THAYER-MARTIN X AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K800089 03/03/1980 CRAWFORD LACRIMAL INTUBATION SET JEDMED INSTRUMENT CO.
K800443 03/10/1980 HYGROTHERM JEDMED INSTRUMENT CO.
K800442 03/10/1980 VARIOTHERM JEDMED INSTRUMENT CO.
K800456 03/18/1980 EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. KHI, INC.
K800518 03/20/1980 UTAGE-MATSU-MICRO-THIN UTAGE-SAKURA, KOPHARM, INC.
K800223 03/03/1980 PATIENT POSITIONING SYSTEM 1D OR 2D LABORATOIRE NATIONAL D'ESSAIS
K800180 03/19/1980 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER LABORATORY PRODUCTS, INC.
K800112 03/10/1980 AMBLYOPIA TRAINER LIFE-TECH INSTRUMENTS, INC.
K800319 03/03/1980 ALPHA DETECTOR M.O.E ELECTRONICS RESEARCH & PROD.
K792115 03/03/1980 BIOFEEDBACK DEVICES & ACCESSORIES M.O.E ELECTRONICS RESEARCH & PROD.
K800337 03/25/1980 DVT PREVENTION SYS. "MBE 22 PRESSURE U. MED-BIO ENGINEERING, INC.
K800509 03/25/1980 CONNECTING TUBES MEDI-CRAFT LTD.
K800506 03/25/1980 OXYGEN CATHETER MEDI-CRAFT LTD.
K800504 03/18/1980 OXYGEN CONNECTING TUBES MEDI-CRAFT LTD.
K800503 03/18/1980 SUCTION CATHETER MEDI-CRAFT LTD.
K800490 03/12/1980 STERILE DRESSING PACK MEDI-SPEC
K800461 03/12/1980 CENTRAL VENOUS PRESSURE CATHETER MEDICAL COMPONENTS, INC.
K800463 03/10/1980 ESOPHAGEAL STETHESCOPE MEDICAL COMPONENTS, INC.
K800462 03/19/1980 PERCUTANEOUS INTRODUCER SET MEDICAL COMPONENTS, INC.
K800331 03/05/1980 SURGITEK FOERSTER FACE LIFT DRAIN MEDICAL ENGINEERING CORP.
K800281 03/12/1980 MEDSPEC PACKING GAUZE MEDSPEC CORP.
K800277 03/12/1980 MEDSPEC RAYON BALLS MEDSPEC CORP.
K800280 03/12/1980 MEDSPEC RUBBER ELASTIC BANDAGES MEDSPEC CORP.
K792715 03/19/1980 SMITH'S SYSTEMIC FUNGAL MEDIUM MERIDIAN DIAGNOSTICS, INC.
K800227 03/03/1980 ML-800 CO2 MERRIMACK LABORATORIES
K800242 03/03/1980 MICRO MEDICAL DATA SYSTEM II MICRO/TEL., INC.
K800365 03/10/1980 EARSCOPE NASH & ASSOC.
K800005 03/05/1980 ECG MONITOR OSCILLOSCOPE MODEL OEC-3100 NIHON KOHDEN AMERICA, INC.
K800004 03/05/1980 ECG MONITOR OSCILLOSCOPE MODEL OEC-3200 NIHON KOHDEN AMERICA, INC.
K800185 03/03/1980 SANITARY NAPKINS MAXI-30 NO FRILLS DISCOUNT FOODS, INC.
K800388 03/12/1980 NML 5000 AUTO. GAMMA SCINT. COUNTER NUCLEAR MEDICAL LABORATORIES, INC.
K800310 03/05/1980 ORTHO ANTISERA CONTROL ORTHO DIAGNOSTICS, INC.
K800244 03/19/1980 BEHIND EAR HEARING AID MODEL E24C1 OTICON CORP.
K800265 03/12/1980 BORDETELLA SELECTIVE SUPPLEMENT OXOID U.S.A., INC.
K800266 03/12/1980 CAMPYLOBACTER GROWTH SUPPLEMENT OXOID U.S.A., INC.
K800257 03/12/1980 CAMPYLOBACTER SELECTIVE SUPPLEMENT OXOID U.S.A., INC.
K800267 03/12/1980 CAMPYLOBACTER SELECTIVE SUPPLEMENT OXOID U.S.A., INC.
K800264 03/12/1980 CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT OXOID U.S.A., INC.
K800261 03/12/1980 DERMASEL SUPPLEMENT OXOID U.S.A., INC.
K800253 03/12/1980 MYCOPLASMA SUPPLEMENT G OXOID U.S.A., INC.
K800254 03/12/1980 MYCOPLASMA SUPPLEMENT P OXOID U.S.A., INC.
K800259 03/12/1980 OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT OXOID U.S.A., INC.
K800262 03/12/1980 PERFRINGENS SUPPLEMENT A OXOID U.S.A., INC.
K800263 03/12/1980 PERFRINGENS SUPPLEMENT B OXOID U.S.A., INC.
K800258 03/12/1980 STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT OXOID U.S.A., INC.
K800252 03/12/1980 STERILE GC SUPPLEMENT OXOID U.S.A., INC.
K800255 03/12/1980 STERILE GC SUPPLEMENT (W/O ANTIBIOTICS) OXOID U.S.A., INC.
K800260 03/12/1980 STREPTOCOCCUS SUPPLEMENT OXOID U.S.A., INC.
K800256 03/12/1980 TINSDALE SUPPLEMENT OXOID U.S.A., INC.
K800517 03/20/1980 TOBRAM E.R.A. TM P-L BIOCHEMICALS, INC.
K800133 03/03/1980 PANOREX II DENTAL X-RAY UNIT PENNWALT CORP.
K800063 03/03/1980 XR-710 PENNWALT CORP.
K792349 03/12/1980 SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. PFIZER, INC.
K800362 03/12/1980 FLUID DISPENSING SYSTEM PHARMASEAL LABORATORIES
K800453 03/20/1980 PHOTOVOLT PVA 4M+2 ANALYZER PHOTOVOLT CORP.
K800492 03/18/1980 VSM-1 PHYSIOLOGICAL MONITOR PHYSIO-CONTROL CORP.
K800332 03/05/1980 RADIOEAR MODEL 2080 (HEARING AID) RADIOEAR CORP.
K800551 03/25/1980 TRIGLYCERIDES TEST (500NM) REAGENTS APPLICATIONS, INC.
K800287 03/19/1980 CEPH LACTAM DISK REMEL CO.
K792675 03/19/1980 CHARCOAL YEAST EXTRACT(CYE) AGAR REMEL CO.
K792252 03/12/1980 DMS 3000 RENAL CARE CORP.
K800397 03/10/1980 ELLIK BLADDER EVACUATOR SAGE PRODUCTS, INC.
K800297 03/05/1980 SANDARE FAST 340 PHOSPHOROUS PROCEDURE SANDARE CHEMICAL CO., INC.
K800439 03/12/1980 ADR COMPOSITE RESTORATIVE SCIENTIFIC PHARMACEUTICALS, INC.
K800438 03/12/1980 DENTAL CAVITY VARNISH, CONCENTRATED SCIENTIFIC PHARMACEUTICALS, INC.
K800114 03/05/1980 SIEMENS-ELEMA AB MANUAL VENTILATION SIEMENS ELEMA AB
K800301 03/05/1980 SIGMA PROCEDURE & REAGENT SYSTEM #335-UV SIGMA CHEMICAL CO.
K800401 03/12/1980 INFRASONDE D4000 ELECTRONIC B-P MONITOR SPHYGMETRICS, INC.
K800526 03/18/1980 SMR H-CHAIR SURGICAL MECHANICAL RESEARCH, INC.
K800029 03/12/1980 SURGICOT 2 INDICATOR SYSTEM SURGICOT, INC.
K800276 03/17/1980 RITTER MODEL H COMPANION STOOL SYBRON CORP.
K800245 03/03/1980 EMIT AUTO CORTISOL ASSAY SYVA CO.
K800225 03/10/1980 MICRONTA BP-1 ELECTRONIC B/P TESTER TANDY CORP.
K800385 03/19/1980 ANALYTE T4-THYROXINE TECHNICON INSTRUMENTS CORP.
K800384 03/19/1980 SMAC SYSTEM, T4 METHOD TECHNICON INSTRUMENTS CORP.
K800573 03/25/1980 IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC TELECTRONICS, INC.
K800603 03/25/1980 IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD. TELECTRONICS, INC.
K800448 03/05/1980 WATER PIK TRAVELER, MODEL 79 TELEDYNE, INC.
K800486 03/19/1980 STIM-EX 201 TH CHARTERS, INC.
K800546 03/25/1980 BUNN VOLUMAIRE RESPIRATORY EXERCISER THE JOHN BUNN CO.
K800087 03/19/1980 ULTRASONIC FLOWMETER THE PERKIN-ELMER CORP.
K800064 03/25/1980 WATER JEL FIRE BLANKET TRILLING RESOURCES, LTD.
K800529 03/20/1980 CENTRIFICHEM BUN UNION CARBIDE CORP.
K800304 03/12/1980 CENTRIFICHEM FILTER CALIBRATION SET UNION CARBIDE CORP.
K800520 03/18/1980 DENTAL STOOLS, #'S P2212, P1121, ETC. VACUDENT SALES CORP.
K800523 03/20/1980 MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC. VARIAN ASSOC., INC.
K800363 03/10/1980 PARKE-DAVIS TOTAL KNEE PROSTHESIS WARNER-LAMBERT CO.
K800160 03/03/1980 SUN-TANNING BOOTHS WORLD WIDE SUN SYSTEMS, INC.
K800512 03/25/1980 ELECTRONIC CLINICAL THERM. MODEL 811A Y


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