FDA 510(k) Applications Received During April, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K770709 04/18/1977 PROBE, TEMPERATURE, SYSTEM, SARNS 3M HEALTH CARE, SARNS
K770744 04/22/1977 IV SET THAT REVERTS TO KVO RATE ABBOTT LABORATORIES
K770743 04/22/1977 SOLUSET FOR IV FAT EMULSION ABBOTT LABORATORIES
K770754 04/25/1977 DUODENOSCOPE, MOLEL TX-6 AMERICAN CYSTOCOPE MAKERS, INC.
K770674 04/11/1977 CURETTE, UTERINE, VACUUM ASPIRATING AMERICAN HOSPITAL SUPPLY CORP.
K770747 04/22/1977 REAGENT SET, CHOLESTEROL, CAT NO. 4024 AMERICAN MONITOR CORP.
K770779 04/29/1977 PHENYTOIN RIA KIT AMERSHAM CORP.
K770652 04/06/1977 FLUORESCENCE ILLUMINATOR ACCESSORY BAUSCH & LOMB, INC.
K770722 04/19/1977 THROMBO SCREEN QUANTITATIVE HEPARIN ASSA BAY AREA HEMA. ONCO. CLINIC. & RES. L
K770731 04/20/1977 EAGENT SYSTEM, CORTISOL, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770655 04/06/1977 LATELET DETERMIBATION KIT, UL 800 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770732 04/20/1977 REAGENT SYSTEM, PROGESTERONE, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770733 04/20/1977 REAGENT SYSTEM, THYROXINE, ARIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770654 04/06/1977 UN, UV DELTA TEST ASSAY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770750 04/25/1977 REAGENT KIT, ENZYMATIC AMYLASE BECKMAN INSTRUMENTS, INC.
K770663 04/07/1977 FEEDBACK EMG SYSTEM, MODEL PE-L00 BIO-FEEDBACK SYSTEMS, INC.
K770648 04/05/1977 QUANTIMUNE T-3 RIA BIO-RAD
K770774 04/28/1977 LYTETEK SYSTEM BOEHRINGER MANNHEIM CORP.
K770692 04/14/1977 MONITOR, FETAL, NO. L04-1100 BRATTLE INSTRUMENT CORP.
K770647 04/05/1977 ELECTROSURGICAL GROUNDING CABLE C.R. BARD, INC.
K770646 04/05/1977 ELECTROSURGICAL PATIENT GROUNDING PAD C.R. BARD, INC.
K770715 04/18/1977 GENERATOR, PULSE, BIPOLAR, MODEL #604 CARDIAC PACEMAKERS, INC.
K770716 04/18/1977 GENERATOR, PULSE, UNIPOLAR, MODEL #504 CARDIAC PACEMAKERS, INC.
K770802 04/26/1977 MARKERS, STAINLESS STEEL CARDIO-SURGICAL, INC.
K770682 04/11/1977 STERILIZER, SERIES 3000, MODIFICATION TO CASTLE CO.
K770736 04/21/1977 MONITOR, PATIENT, MODEL PM-20N CAVITRON CORP.
K770713 04/18/1977 MONITOR, PATIENT, RESP. CARBON DIOXIDE CAVITRON CORP.
K770723 04/19/1977 TABLE, TREATMENT, THERAPY, PHYSICAL CHATTANOOGA PHARMACAL CO.
K770724 04/19/1977 TRACTION DEVICES, INTERMITTENT, TX CHATTANOOGA PHARMACAL CO.
K770780 04/29/1977 REAGENTS CHEMETRICS CORP.
K770702 04/18/1977 IN VITRO FERRITIN RIA TEST CLINICAL ASSAYS, INC.
K770672 04/08/1977 COLLECTOR, SANI-CATCH, NO. 1010 CONCORD LABORATORIES, INC.
K770673 04/08/1977 COLLECTOR, SANI-CATCH, NO. 1014 CONCORD LABORATORIES, INC.
K770662 04/07/1977 VIEWER, FLUOROMETIC, MODEL 721 CORNING MEDICAL & SCIENTIFIC
K770679 04/11/1977 CHEMISTRY, COULTER COULTER ELECTRONICS, INC.
K770752 04/25/1977 REAGENT, CHLORIDE, COULTER COULTER ELECTRONICS, INC.
K770751 04/25/1977 CATHETERS, OVER-THE-NEEDLE CUTTER LABORATORIES, INC.
K770742 04/22/1977 CUTTER CAST 7 CUTTER LABORATORIES, INC.
K770678 04/11/1977 ELC-THERMO-SYSTEM CUTTER LABORATORIES, INC.
K770619 04/01/1977 EXERCISOR, RESPIRATORY CUTTER LABORATORIES, INC.
K770776 04/28/1977 TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK CUTTER LABORATORIES, INC.
K770759 04/25/1977 HOOK HOLLER DEPUY, INC.
K770698 04/15/1977 COUNTER, SPONGE DEVON INDUSTRIES, INC.
K770620 04/01/1977 TUBING FEEDING KIT DOYLE PHARMACEUTICAL
K770730 04/20/1977 PUMP, INFUSION, DYNATECH/HANDLEY DYNATECH MEDICAL PRODUCTS
K770651 04/06/1977 RETRACTORS & HOOKS, ABRAMSON EDWARD WECK, INC.
K770656 04/07/1977 GENERATOR, PULSE, CARDIAC 20U EDWARDS PACEMAKER SYSTEMS
K770657 04/07/1977 GENERATOR, PULSE, CARDIAC 2LU EDWARDS PACEMAKER SYSTEMS
K770686 04/12/1977 THERATHERM ELECTRO THERAPEUTIC DEVICES, INC.
K770777 04/28/1977 THERMOMETER, ELECTRONIC, DIGIMED HOL ELMED, INC.
K770773 04/28/1977 PIPETTE, DILUTING, MODEL ADP-30SD G.D. SEARLE AND CO.
K770772 04/28/1977 PIPETTE, DISPENSING, MODEL ADP-30SD G.D. SEARLE AND CO.
K770740 04/21/1977 RADIOASSAY TUBES & RADIOASSAY TUBE CAPS G.D. SEARLE AND CO.
K770765 04/27/1977 REAGENT SET, RENORPACE G.D. SEARLE AND CO.
K770737 04/21/1977 REAGENT SET, T-4, CPB G.D. SEARLE AND CO.
K770738 04/21/1977 REAGENT, T-3 UPTAKE G.D. SEARLE AND CO.
K770739 04/21/1977 SERUM SET, THYROID CONTROL G.D. SEARLE AND CO.
K770677 04/11/1977 T-3 RIA REAGENT SET G.D. SEARLE AND CO.
K770676 04/11/1977 T-4 RIA REAGENT SET G.D. SEARLE AND CO.
K770691 04/14/1977 GAMBRO VENOUS BLOOD LINE GAMBRO, INC.
K770760 04/25/1977 MONITOR, PORTABLE, PATIENT, G.E. GENERAL ELECTRIC CO.
K770753 04/25/1977 PORTA CAMERA IIC GENERAL ELECTRIC CO.
K770680 04/11/1977 HEMATRAK GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770701 04/18/1977 HEMATRAK MODEL 125 GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770683 04/12/1977 BOTTLE, BLOOD CULTURE, BI-PHASIC GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770650 04/06/1977 PRE-DUCED CULTURE MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770766 04/28/1977 REGULATOR, PRESSURE, EXPIRATORY GLOBE SAFETY PRODUCTS, INC.
K770623 04/04/1977 CONDUCTIVE CREAM-500 GRAPHIC CONTROLS CORP.
K770622 04/04/1977 CONDUCTIVITY GEL W/POTASSIUM CHLORIDE GRAPHIC CONTROLS CORP.
K770694 04/15/1977 CPK ULTRAZYME PLUS HARLECO DIAGNOSTICS
K770615 04/01/1977 1304A X-Y DISPLAY INTRODUCTION HEWLETT-PACKARD CO.
K770755 04/25/1977 ECHOCARDIOGRAPHY SYS., MODEL 3830 HONEYWELL, INC.
K770756 04/25/1977 ECHOCARDIOGRAPHY SYS., MODEL 3860 HONEYWELL, INC.
K770757 04/25/1977 PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 HONEYWELL, INC.
K770690 04/13/1977 MASK, VAPOR, MONOMER HOWMEDICA CORP.
K770771 04/28/1977 AEROSOL EFFUSION SYSTEM #1740 HUDSON OXYGEN THERAPY SALES CO.
K770643 04/04/1977 CREATININE TEST, SUPER SEVENTEEN HYCEL, INC.
K770748 04/22/1977 TEST, FERROZINE IRON & IRON BINDING HYCEL, INC.
K770636 04/04/1977 TABLE, EXAM & MANUPULATION I E INDUSTRIES
K770634 04/04/1977 ADAPTER BE 105-101 & 125-101 INSTRUMENTATION INDUSTRIES, INC.
K770630 04/04/1977 ADAPTER, UNIVERSAL, BE 105-6 INSTRUMENTATION INDUSTRIES, INC.
K770627 04/04/1977 ADAPTER, VALVE, ONE WAY BE-130-22 INSTRUMENTATION INDUSTRIES, INC.
K770633 04/04/1977 BRACKET BE 122-1 INSTRUMENTATION INDUSTRIES, INC.
K770628 04/04/1977 CLAMP BE-152 INSTRUMENTATION INDUSTRIES, INC.
K770631 04/04/1977 FLEX ARM BE 122, CLAMP 122-27 INSTRUMENTATION INDUSTRIES, INC.
K770632 04/04/1977 GAS COLLHCTOR BE 155(155-2-3,154-4) INSTRUMENTATION INDUSTRIES, INC.
K770629 04/04/1977 VALVE, EXHALATION BE 115-4, 115-5 INSTRUMENTATION INDUSTRIES, INC.
K770660 04/07/1977 ANALYZER, CENTRIFUGAL, IL MULTISTAT III INSTRUMENTATION LABORATORY CO.
K770645 04/05/1977 SPECTROPHOTOMETER, MODEL 751 INSTRUMENTATION LABORATORY CO.
K770705 04/18/1977 CARDIAC ACQUISITION SYSTEM, ICR 2001 INSTRUMENTS FOR CARDIAC RESEARCH
K770664 04/07/1977 NEBULIZER J & S INDUSTRIES, INC.
K770725 04/19/1977 STIMULATOR, MUSCLE, MODEL 107 JAYTRONICS, INC.
K770749 04/25/1977 TOOTHBRUSH, REACH JOHNSON & JOHNSON PROFESSIONALS, INC.
K770719 04/18/1977 IMMUNOELECTROFILM KIH KALLESTAD LABORATORIES, INC.
K770718 04/18/1977 STAIN, R-250, COOMASSIE BRILLIANT BLUE KALLESTAD LABORATORIES, INC.
K770670 04/08/1977 FLOR. CONJUG. HUMAN FAB FRAGMENT KENT LABORATORIES, INC.
K770668 04/08/1977 FLUORESCEIN CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770669 04/08/1977 RHODAMINE-CONJUGATED ANTISERUM KENT LABORATORIES, INC.
K770675 04/11/1977 COMPUTER, CARDIAC OUTPUT, MODEL KM275 LEXINGTON INSTRUMENTS
K770616 04/01/1977 AUDIOMETER, MA29, PURE TONE AIR CONDUCT. MAICO HEARING INSTRUMENTS, INC.
K770617 04/01/1977 AUDIOMETER, MA30, AIR & BONE CONDUCTION MAICO HEARING INSTRUMENTS, INC.
K770618 04/01/1977 AUDIOMETER, MA31 MAICO HEARING INSTRUMENTS, INC.
K770714 04/18/1977 CATHETER, ARTERIAL EMBOLECTOMY MALLINCKRODT CRITICAL CARE
K770706 04/18/1977 CATHETER, IRRIGATION MALLINCKRODT CRITICAL CARE
K770665 04/08/1977 VALVE, PRESSURE, DEMAND MCGAW RESPIRATORY THERAPY
K770661 04/07/1977 GENERATOR, PULSE, IMPLANTABLE MED TELECTRONICS LTD.
K770758 04/25/1977 INJECTION SYSTEM, MDC I.V. MEDICAL DEVELOPMENT CO.
K770649 04/06/1977 VAC-RITE MEDICAL DEVELOPMENT CO.
K770699 04/18/1977 NEEDLE SET, A-V FISTULA MEDICAL DISPOSABLES INTL., INC.
K770641 04/04/1977 MINI-CONER TM MEDICAL TESTING SYSTEM, INC.
K770745 04/22/1977 PANEL, GNF, MICRO-ID MICRO-MEDIA SYSTEMS, INC.
K770746 04/22/1977 PANEL, IDENTIFICATION, STREP, MICRO-ID MICRO-MEDIA SYSTEMS, INC.
K770687 04/13/1977 MEASLESVIRUS FLOURE. CONJUGATED ANTISERU MICROBIOLOGICAL ASSOC.
K770764 04/27/1977 TISSUE CULTURE MEDIA W/HEPES BUFFER MICROBIOLOGICAL ASSOC.
K770659 04/07/1977 RIALYZE HPL (RIA) MILES LABORATORIES, INC.
K770703 04/18/1977 FILTER UNIT, SINGLE USE MILLIPORE CORP.
K770728 04/20/1977 INTRAOCULAR LENS MILTON ROY CO. ANALYTICAL
K770727 04/19/1977 MANIPULATOR & INJECTOR, UTERINE NATIONAL CATHETER CO. DIV. MALLINCKRODT
K770642 04/04/1977 SYRINGE, ENDODONTIC W/NOTCHED TIP NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K770903 04/18/1977 STERILE CONTINER, X-RAY CASSETTE HOLDER NORTH SHORE ORTHOPAEDIC GROUP, S.C.
K770707 04/18/1977 TYGON PAC-MONITORING LINES & FLUID ADMIN NORTON PERFORMANCE PLASTICS CORP.
K770708 04/18/1977 TYGON PAC-STOPCOCKS NORTON PERFORMANCE PLASTICS CORP.
K770684 04/12/1977 CROWN, ACRYLIC, CORAL BRAND, PREFORMED PARKER LABORATORIES, INC.
K770685 04/12/1977 LIGHT, EXAMINING, DENTAL, ULTRA VIOLET PARKER LABORATORIES, INC.
K770639 04/04/1977 DETECTOR, IR, MODEL GC-33 PEOKIN-ELMER CORP.
K770638 04/04/1977 DETECTOR, UV, MOLEL GC-55 PEOKIN-ELMER CORP.
K770778 04/29/1977 MAXI-PADS, STAYFREE PERSONAL PRODUCTS CO.
K770697 04/15/1977 COLPOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770710 04/18/1977 NEEDLE, SPRAY RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770729 04/20/1977 PYELOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770712 04/18/1977 TROCAR SLEEVE SYSTEM 4MM TO 3.4MM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770711 04/18/1977 TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770658 04/07/1977 EXERCISER, LEG, LOWER EXTREMITY ROBERT R. MOORE
K770681 04/11/1977 VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR SCIMED LIFE SYSTEMS, INC.
K770767 04/28/1977 IN VITRO DIAG. FOR URIC ACID SMITH KLINE DIAGNOSTICS, INC.
K770717 04/18/1977 IONTOPHORESIS SYSTEM MODULE, DM 500 SORENSEN RESEARCH
K770726 04/19/1977 RIA KIT, T4 CLASP SQUIBB & SONS, INC.
K770667 04/08/1977 CHROMASCAN TM STERNDENT CORP.
K770666 04/08/1977 HEMALOG 8/90 TECHNICON INSTRUMENTS CORP.
K770695 04/15/1977 MONITOR, BED, TECHNOLICS TECHNOLICS, INC.
K770635 04/04/1977 PROTECTOR, HEEL & ELBOW TECNOL NEW JERSEY WOUND CARE, INC.
K770640 04/04/1977 GRAPHITE ATOMIZER, HGA-76B THE PERKIN-ELMER CORP.
K770637 04/04/1977 MERCURY/HYDRIDE SYSTEM MHS-1 THE PERKIN-ELMER CORP.
K770721 04/18/1977 MONITORS, REMOTE, RMS III THE PERKIN-ELMER CORP.
K770621 04/01/1977 STOCKINETTE, SURGICAL THE TORRENT CORP.
K770704 04/18/1977 GLOVES, SURGEONS, LATEX TILLOTSON RUBBER CO., INC.
K770762 04/26/1977 BAG, URINARY, DRAINAGE, 2D9013 TRAVENOL LABORATORIES, S.A.
K770763 04/26/1977 BURETTE SET, 2C0132 TRAVENOL LABORATORIES, S.A.
K770735 04/21/1977 DIALYZER, COIL, CD, LSA, 5M1765 TRAVENOL LABORATORIES, S.A.
K770734 04/21/1977 DIALYZER, FIBER, HOLLOW TRAVENOL LABORATORIES, S.A.
K770671 04/08/1977 CALCULATOR, ENZYME, TURNER TURNER ASSOC.
K770644 04/04/1977 ULTRASOUND B-SCANNING SYSTEM UNIRAD CORP.
K770768 04/28/1977 OPHTHALMOSCOPE, MODEL #11100 WELCH ALLYN, INC.
K770769 04/28/1977 OTOSCOPE/ILLUMINATOR, MODEL #21100 WELCH ALLYN, INC.
K770770 04/28/1977 WALL CHARGER, MODEL #79111 WELCH ALLYN, INC.
K770689 04/13/1977 HEARING AID MODEL A8H AND A8T WIDEX HEARING AID CO., INC.
K770688 04/13/1977 HEARING AID MODEL F8H ANL F8T WIDEX HEARING AID CO., INC.
K770720 04/18/1977 TUBING PACK, EXTRACORPOREAL, H-3000 WILLIAM HARVEY LIFE PRODUCTS CORP.
K770693 04/13/1977 X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC XONICS MEDICAL SYSTEMS, INC.


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