FDA 510(k) Decisions During October, 1976  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K760756 10/15/1976 BATTERY OPERATED FLOW RATE COMPUTER 3M HEALTH CARE, SARNS
K760721 10/06/1976 MEDICAL OSCILLOSCOPE MEMORY SCOPE ABBOTT LABORATORIES
K760655 10/05/1976 ANEROID SPHYGMOMANOMETER ABCO DEALERS, INC.
K760327 10/20/1976 WHEEL'N WEIGH ACME MEDICAL SCALE CO.
K760703 10/21/1976 SPONGE AND GAUZE FORCEP PART #S-417-9 ACME UNITED CORP.
K760816 10/29/1976 PNEUMOTACHOGRAPHY SYSTEM AFTERCAL, INC.
K760440 10/20/1976 CATHETER, NATURAL LATEX URETHRAL AKRON CATHETER, INC.
K760822 10/21/1976 MODEL TX-8 PANENDOSCOPE AMERICAN CYSTOCOPE MAKERS, INC.
K760201 10/05/1976 X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC AMERICAN SCIENCE AND ENGINEERING, INC.
K760806 10/21/1976 REFEREE AQUEOUS TRIGLYCERIDE STND ANALYTICAL PRODUCTS, INC.
K760689 10/05/1976 NERVEL-NERVE CONDUCTION VELOCITY METER BAK ELECTRONICS
K760583 10/03/1976 DISPOSABLE/BOROSILICATE CULTURE TUBES BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760588 10/07/1976 IMPROVED THAYER MARTIN MEDIUM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760641 10/08/1976 MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760643 10/08/1976 MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760587 10/15/1976 U-MID PREFILLED HUMIDIFIER (300CC) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760584 10/15/1976 U-MID PREFILLED HUMIDIFIER (500CC) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760585 10/15/1976 U-MID PREFILLED NEBULIZER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760589 10/07/1976 VCA INHIBITOR BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760730 10/07/1976 ANTICONVULSANT CONTROL SERUM BIO-REAGENTS & DIAGNOSTICS, INC.
K760764 10/29/1976 YEAST ASSIMILATION AGAR BIOQUEST
K760596 10/08/1976 BIOTROL-ABNORMAL BOEHRINGER MANNHEIM CORP.
K760597 10/08/1976 BIOTROL-NORMAL BOEHRINGER MANNHEIM CORP.
K760506 10/28/1976 HEMAFLOUR ZP BUCHLER INSTRUMENTS, INC.
K760266 10/13/1976 MONITOR, ELECTROCARDIOSCOPE BURDICK CORP.
K760787 10/22/1976 LIBERATOR/STROLLER BURDITT & CALKINS-SIEMENS-ELEMA
K760773 10/08/1976 IMPEDANCE TESTER (MODEL 4370) CAMBRIDGE INSTRUMENTS, INC.
K760776 10/08/1976 IMPEDANCE TESTER (MODEL 4390) CAMBRIDGE INSTRUMENTS, INC.
K760600 10/15/1976 CARDIAC OUTPUT COMPUTER CARDIOPULMONARY INSTRUMENTATION
K760805 10/21/1976 ULTRASONIC DENTAL PROPHYLAXIS DEVICE CAVITRON CORP.
K760252 10/15/1976 DIALYZER, HF 130 HOLLOW FIBER COBE LABORATORIES, INC.
K760665 10/21/1976 FISTULA NEEDLE (#11-265) COBE LABORATORIES, INC.
K760770 10/15/1976 SOLA COMMIDO LOUPE CODMAN & SHURTLEFF, INC.
K760771 10/15/1976 SOLA SCHULTZE-CROCK OPTHALMOSCOPE CODMAN & SHURTLEFF, INC.
K760105 10/07/1976 BAG, URINE COLLECTION, CLOSED SYSTEM CONCORD LABORATORIES, INC.
K760128 10/07/1976 TRAY, CATHETERIZATION W/ CATHETER CONCORD LABORATORIES, INC.
K760127 10/07/1976 TRAY, CATHETERIZATION W/O CATHETER CONCORD LABORATORIES, INC.
K760682 10/08/1976 4C ABNORMAL LOW-HIGH (8 X 6 M1) COULTER ELECTRONICS, INC.
K760664 10/05/1976 CRAWFORD PORTAVAC CRAWFORD ELECTRIC
K760752 10/15/1976 CUTTER FLEX-SILICONE IMPRESSION MAT. CUTTER LABORATORIES, INC.
K760753 10/20/1976 CUTTER JEL-ALGINATE IMPRESSION MAT. CUTTER LABORATORIES, INC.
K760755 10/15/1976 CUTTER SIL-SILICONE IMPRESSION MAT CUTTER LABORATORIES, INC.
K760754 10/15/1976 CUTTER TRAY-ACRYLIC FOR IMP TRAYS CUTTER LABORATORIES, INC.
K760744 10/07/1976 TAVERNETTI-TENNANT CUTTER LABORATORIES, INC.
K760549 10/08/1976 PLATELET CONTROLS, NORMAL & ABNORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760719 10/29/1976 UNIFORM DROP SIZE PASTEUR TYPE PIPETS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760803 10/20/1976 PHYSIOLOGICAL MONITOR (MODEL 870) DATASCOPE CORP.
K760750 10/08/1976 STERILE TUBULAR UNBLEACHED STOCKINETTE DENNISON MANUFACTURING CO.
K760783 10/15/1976 BIOBOND-CROWN & BRIDGE CERAMIC BONDING DENTSPLY INTL.
K760649 10/05/1976 TOTAL SPINAL CORRECTION DEPUY, INC.
K760802 10/29/1976 T-3 UPTAKE KIT DIAGNOSTIC PRODUCTS CORP.
K760636 10/05/1976 ORTHOMIX DIEMOLDING CORP.
K760763 10/20/1976 COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I DYNATECH CRYOMEDICAL CO.
K760374 10/27/1976 DIALYZER (MODEL 1850) ERIKA, INC.
K760718 10/14/1976 PERISTALTIC INFUSION PUMP (2100,2101) EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K760768 10/15/1976 FLEXIDENT DENTURE FLEXODENT CORP.
K760606 10/08/1976 HA ANTIGEN FLOW LABORATORIES, INC.
K760607 10/08/1976 HI CHICKEN ANTISERUM FLOW LABORATORIES, INC.
K760608 10/08/1976 HI CHICKEN PRESERUM FLOW LABORATORIES, INC.
K760692 10/07/1976 MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN FLOW LABORATORIES, INC.
K760693 10/07/1976 NEIGON JEMBEC PLATE WITH ANIXOMYCIN FLOW LABORATORIES, INC.
K760691 10/07/1976 THAYER-MARTIN MEDIUM W/TRIMETHOPRIN L FLOW LABORATORIES, INC.
K760690 10/07/1976 THAYER-MARTIN MEDIUM WITH ANSIOMYCIN FLOW LABORATORIES, INC.
K760566 10/15/1976 PREFILLED HUMIDIFIER FOREGGER AIR PRODUCTS & CHEM., INC.
K760766 10/08/1976 PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER FRASER SWEATMAN, INC.
K760725 10/27/1976 COIL MACHINE ADAPTER GAMBRO, INC.
K760706 10/06/1976 MUL-T-PAD GAYMAR INDUSTRIES, INC.
K760804 10/15/1976 T-PUMP, TEMPERATURE - THERAPY PUMP GAYMAR INDUSTRIES, INC.
K760790 10/29/1976 MICRO-ID GENERAL DIAGNOSTICS
K760688 10/05/1976 CT/N-II SCANNER SYSTEM GENERAL ELECTRIC CO.
K760333 10/27/1976 JAR, COLLECTOR FOR SUCTION SYSTEMS HARRIS-LAKE, INC.
K760774 10/13/1976 TIME-SHARING MULTIPLEXER (MODEL 78308A) HEWLETT-PACKARD CO.
K760767 10/13/1976 MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM HONEYWELL, INC.
K760735 10/15/1976 BONGORT "SPECIAL" ODORPROOF DRAIN HOWMEDICA CORP.
K760842 10/20/1976 GEOMEDIC ANAMETRIC TOTAL KNEE HOWMEDICA CORP.
K760499 10/29/1976 REAGENT, PARTIAL THROMBOPLASTIN HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760762 10/08/1976 INCENTIVE SPIROMETER I-SPIRON
K760260 10/20/1976 BAG, DISPOSABLE URINARY LEG INTERMED, INC.
K760410 10/29/1976 AMP BUFFER J.T. BAKER CHEMICAL CO.
K760406 10/29/1976 CAFFEINE DILUENT J.T. BAKER CHEMICAL CO.
K760411 10/29/1976 NAD (SPOONPAK CONTAINER) J.T. BAKER CHEMICAL CO.
K760398 10/29/1976 REAGENT, MAGNESIUM CHLORIDE J.T. BAKER CHEMICAL CO.
K760407 10/29/1976 SULFANILIC ACID J.T. BAKER CHEMICAL CO.
K760008 10/05/1976 DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL KYOCERA INTERNATIONAL, INC.
K760467 10/29/1976 ROTATOR, FIXED SPEED LEDERLE LABORATORIES
K760355 10/05/1976 TEST, SEROSONIC ALBUMIN MALLINCKRODT CRITICAL CARE
K760550 10/05/1976 IMPLANT, SILICONE AND TANTALUM MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K760613 10/14/1976 FLOTATION UNIT, CHAIR MEDPRO, INC.
K760751 10/13/1976 CONTINUOUS WAVE DOPPLER MEDSONICS
K760728 10/06/1976 CONTINUOUS WAVE DOPPLER ULTRASOUND MEDSONICS
K760605 10/05/1976 LIGHTCAST II CARBIDE BLADE MERCK, SHARP & DOHME
K760795 10/20/1976 FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. MIDWEST
K760794 10/20/1976 FIBER OPTICS HIGH SPEED HANDPIECE MIDWEST
K760796 10/20/1976 ORALUMINATOR III - LIGHT SOURCE FOR F.O. MIDWEST
K760472 10/29/1976 INSTRUMENTED SYSTEM FOR URINALYSIS MILES LABORATORIES, INC.
K760264 10/06/1976 CURETTE, PROPOSED TIS-U-TRAP, METAL MILEX PRODUCTS, INC.
K760741 10/05/1976 PORTABLE X-RAY MINXRAY, INC.
K760820 10/20/1976 NALGENE EMERGENCY EYE WASH NAGLE CO.
K760819 10/27/1976 CONDUCTIVE ANESTHESIA BREATHING CIRCUIT OMNICON MEDICAL CORP.
K760651 10/05/1976 TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL ORTHOPEDIC EQUIPMENT CO., INC.
K760817 10/20/1976 ORTHOPEDIC TUBULAR STOCKINETTE PARKE-DAVIS CO.
K760723 10/21/1976 SAFE-T-PINS RETENTIVE PIN SYSTEM PARKELL, INC.
K760069 10/20/1976 BAG, LEG, URINE COLLECTING DEVICE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K760677 10/05/1976 LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5) PHYSIO-CONTROL CORP.
K760676 10/13/1976 LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE PHYSIO-CONTROL CORP.
K760353 10/29/1976 CRYOLYZER ALPHA PILLING CO.
K760360 10/20/1976 SHIRT, MITTEN CUFF INFANT PRECEPT, INC.
K760346 10/27/1976 ASSAY FOR GAMMA GLUTAMYLTRANSFERASE PRINCETON BIOMEDIX
K760347 10/05/1976 SET, TRINDER GLUCOSE PRINCETON BIOMEDIX
K760345 10/27/1976 TEST, LACTATE DEHYDROGENASE PRINCETON BIOMEDIX
K760845 10/27/1976 "SOLO-SPHERE HEATER" RESPIRATORY THERAPY
K760437 10/05/1976 CAUSSE MODIFIED TEFLON PISTON, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760574 10/06/1976 ECONOMY IMMOBILIZATION AND VELPEAN SLING RICHARD'S MEDICAL EQUIP., INC.
K760573 10/05/1976 IMPROVED KNEE DRESSING RICHARD'S MEDICAL EQUIP., INC.
K760577 10/06/1976 RICHARDS CLAVICLE STRAP RICHARD'S MEDICAL EQUIP., INC.
K760575 10/06/1976 ROCKER-SOLE CAST SANDAL RICHARD'S MEDICAL EQUIP., INC.
K760433 10/05/1976 SHEA TORP, OTOLOGY IMPLANT RICHARD'S MEDICAL EQUIP., INC.
K760576 10/05/1976 TOURNIWRAP BANDAGE RICHARD'S MEDICAL EQUIP., INC.
K760434 10/05/1976 TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY RICHARD'S MEDICAL EQUIP., INC.
K760707 10/05/1976 RITTER STARLIGHT DENTAL OPERATING LIGHT RITTER CO.
K760598 10/08/1976 IMPROVED THAYER MARTIN MEDIUM SCOTT LABORATORIES, INC.
K760621 10/05/1976 LANCER PLASTIC TRANSFER PIPETTE SHERWOOD MEDICAL INDUSTRIES
K760350 10/29/1976 MONITOR, CITADEL INTRAVASCULAR PO2 SHERWOOD MEDICAL INDUSTRIES
K760339 10/28/1976 MONITOR, RESPIRATORY (CPAP) SHERWOOD MEDICAL INDUSTRIES
K760349 10/05/1976 BILIRUBIN REF., SIGMA STOCK NO. 605-10 SIGMA CHEMICAL CO.
K760449 10/29/1976 LIPID CONTROL SIGMA CHEMICAL CO.
K760821 10/21/1976 REAGENT SYSTEM SIGMA CHEMICAL CO.
K760348 10/27/1976 REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 SIGMA CHEMICAL CO.
K760591 10/29/1976 SIGMA PROCEDURE NO. 745 - EP.REAGENT SY SIGMA CHEMICAL CO.
K760473 10/29/1976 REAGENT, ALBUMIN DETERMINATION SIMMLER & SON, INC.
K760474 10/29/1976 REAGENT, ALKALINE PHOSPHATASE DETERM. SIMMLER & SON, INC.
K760478 10/29/1976 REAGENT, BUN (UREA NITROGEN) DETERM. SIMMLER & SON, INC.
K760475 10/29/1976 REAGENT, CALCIUM DETERMINATION SIMMLER & SON, INC.
K760479 10/29/1976 REAGENT, TOTAL BILIRUBIN DETERMINATION SIMMLER & SON, INC.
K760480 10/29/1976 REAGENT, TOTAL PROTEIN DETERMINATION SIMMLER & SON, INC.
K760477 10/29/1976 REAGENTS-4 FOR URIC ACID DETERMINATION SIMMLER & SON, INC.
K760631 10/15/1976 FILTER SET 1288 SORENSEN RESEARCH
K760629 10/15/1976 FILTER SET PMF 100 SORENSEN RESEARCH
K760633 10/15/1976 FILTER SET PMF 1028 SORENSEN RESEARCH
K760625 10/15/1976 FILTER SET PMF 1168 SORENSEN RESEARCH
K760630 10/15/1976 FILTER SET PMF 200 SORENSEN RESEARCH
K760632 10/15/1976 FILTER SET PMF 2024 SORENSEN RESEARCH
K760627 10/15/1976 FILTER SET PMF 2168 SORENSEN RESEARCH
K760626 10/15/1976 FILTER SET PMF 2288 SORENSEN RESEARCH
K760628 10/15/1976 FILTER SET PMF 2448 SORENSEN RESEARCH
K760640 10/15/1976 FILTER SET, PMF 1024 SORENSEN RESEARCH
K760637 10/15/1976 FILTER SET, PMF 1448 SORENSEN RESEARCH
K760639 10/15/1976 FILTER SET, PMF 2028 SORENSEN RESEARCH
K760638 10/15/1976 FILTER, PMF 1000 SORENSEN RESEARCH
K760726 10/05/1976 ELECTRO-KERATOTOME, LINE-OPERATED STORZ INSTRUMENT CO.
K760617 10/05/1976 MIX EVAC BONE CEMENT STRYKER CORP.
K760709 10/21/1976 EMIT DIGOKIN ASSAY SYVA CO.
K760672 10/29/1976 CLINICAL SPECTROPHOTOMETER THE DOW CHEMICAL CO.
K760705 10/05/1976 OXYGEN-RICH THE JOHN BUNN CO.
K760046 10/21/1976 CASE, CONTACT LENS, PLASTIC TOMLIN B. HORSLEY, JR.
K760859 10/29/1976 TRACOR MODEL RA 208 COMPLIANCE AUDIOM TRACOR INSTRUMENTS, INC.
K760544 10/20/1976 CATHETER, PERITONEAL DIALYSIS TRAVENOL LABORATORIES, S.A.
K760793 10/15/1976 ADAPTER FOR ELLIK EVACUATOR V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760178 10/15/1976 ELECTRODE, CUTTING LOOP V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760717 10/21/1976 FLEXIBLE BIOPSY FORCEPS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760715 10/21/1976 FLEXIBLE CUTTING SCISSORS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760716 10/15/1976 FLEXIBLE FOREIGN BODY FORCEPS V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760357 10/27/1976 SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI) V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760684 10/05/1976 VISC X-VITREOUS ASPIRATING & CUT. INSTR VARIAN ASSOC., INC.
K760681 10/21/1976 INDIRECT FLUORESCENT (IFA-ANA) WAMPOLE LABORATORIES
K760513 10/15/1976 ELECTRODE, TEMPORARY MYOCARDIAL WINN HIRSCH & ASSOC.
K760704 10/05/1976 OXYGEN-RICH XORBOX
K760695 10/06/1976 TAMARI-KAPLITT YEHUDA TAMARI


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