FDA 510(k) Decisions During May, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K770744 05/26/1977 IV SET THAT REVERTS TO KVO RATE ABBOTT LABORATORIES
K770595 05/23/1977 SUTURE REMOVAL SET ABCO DEALERS, INC.
K770588 05/23/1977 COTTON BALL KIT AMERICAN HOSPITAL SUPPLY CORP.
K770813 05/20/1977 ENDOGATOR AUS-TEX DENTAL MFG. & DESIGN
K770823 05/18/1977 AUDIOMETRIC TESTING SYS., SERIES 500 AUTOMATED TESTING SERVICES, LTD.
K770821 05/06/1977 PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT AVCO MEDICAL PRODUCTS
K770582 05/06/1977 LENS, CONTACT, HARD BEREA CONTACT LENS, INC.
K770790 05/10/1977 FEEDBACK EDR SYSTEM MODEL EDR-100 BIO-FEEDBACK SYSTEMS, INC.
K770647 05/23/1977 ELECTROSURGICAL GROUNDING CABLE C.R. BARD, INC.
K770682 05/20/1977 STERILIZER, SERIES 3000, MODIFICATION TO CASTLE CO.
K770679 05/03/1977 CHEMISTRY, COULTER COULTER ELECTRONICS, INC.
K770751 05/26/1977 CATHETERS, OVER-THE-NEEDLE CUTTER LABORATORIES, INC.
K770678 05/25/1977 ELC-THERMO-SYSTEM CUTTER LABORATORIES, INC.
K770606 05/06/1977 ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH DAMON CORP.
K770344 05/09/1977 SH-1 DELTA MEDICAL INDUSTRIES
K770856 05/23/1977 PROSTHESIS, TRAPEZIUM & TRAPEZIUM TRIAL DEPUY, INC.
K770786 05/18/1977 SPLINTS, FINGER/TOE DEPUY, INC.
K770698 05/06/1977 COUNTER, SPONGE DEVON INDUSTRIES, INC.
K770620 05/03/1977 TUBING FEEDING KIT DOYLE PHARMACEUTICAL
K770837 05/26/1977 SCREEN, FINE, LANES, KODAK EASTMAN KODAK COMPANY
K770782 05/06/1977 FIBERSCOPIC SCOPE RECORDER SYSTEM ELMED, INC.
K770777 05/03/1977 THERMOMETER, ELECTRONIC, DIGIMED HOL ELMED, INC.
K770811 05/20/1977 ADENOVIRUS GROUP-FA LABELLED PRESERUM FLOW LABORATORIES, INC.
K770807 05/20/1977 ADENOVIRUS-GROUP FA LABELLED (8-651 RF) FLOW LABORATORIES, INC.
K770809 05/20/1977 MEASLES-FA LABELED PRESERUM (8-441 RNF) FLOW LABORATORIES, INC.
K770805 05/20/1977 MEASLES-FA LABELLED (8-441 RF) FLOW LABORATORIES, INC.
K770808 05/20/1977 RESP. SYNCYTIAL-FA LABELLED PRESERUM FLOW LABORATORIES, INC.
K770804 05/20/1977 RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) FLOW LABORATORIES, INC.
K770810 05/20/1977 VARICELLA-ZOSTER FA LABELED PRESERUM FLOW LABORATORIES, INC.
K770806 05/20/1977 VARICELLA-ZOSTER FA LABELLED (8-321 RF) FLOW LABORATORIES, INC.
K770910 05/25/1977 MEDISHIELD CERVICAL COLLAR FRASER SWEATMAN, INC.
K770677 05/20/1977 T-3 RIA REAGENT SET G.D. SEARLE AND CO.
K770676 05/20/1977 T-4 RIA REAGENT SET G.D. SEARLE AND CO.
K770783 05/10/1977 FILM PROCESSOR, AUTOMATIC GENERAL ELECTRIC CO.
K770760 05/06/1977 MONITOR, PORTABLE, PATIENT, G.E. GENERAL ELECTRIC CO.
K770753 05/10/1977 PORTA CAMERA IIC GENERAL ELECTRIC CO.
K770476 05/06/1977 EXAM GOWN GENERAL MEDICAL CO.
K770488 05/23/1977 ISOLATION GOWN GENERAL MEDICAL CO.
K770583 05/26/1977 MEDI-PAK LEMON GLYCEOIN SWABS GENERAL MEDICAL CO.
K770766 05/10/1977 REGULATOR, PRESSURE, EXPIRATORY GLOBE SAFETY PRODUCTS, INC.
K770928 05/26/1977 PART NO. 66-00121 HARLAKE CYPRANE
K770927 05/26/1977 PART NO. 66-00311 HARLAKE CYPRANE
K770755 05/09/1977 ECHOCARDIOGRAPHY SYS., MODEL 3830 HONEYWELL, INC.
K770756 05/09/1977 ECHOCARDIOGRAPHY SYS., MODEL 3860 HONEYWELL, INC.
K770757 05/09/1977 PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 HONEYWELL, INC.
K770547 05/03/1977 LAS-R TM HUMAN COMPLEMENT C4 TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K770451 05/03/1977 ALBUMIN PROCEDURE, TEKPOINT BROMCRESOL ICN PHARMACEUTICALS, INC.
K770458 05/10/1977 BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. ICN PHARMACEUTICALS, INC.
K770449 05/03/1977 CALCIUM PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770450 05/03/1977 CHLORIDE PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770457 05/03/1977 CHOLESTEROL PROCEDURE, TEKPOINT TOTAL ICN PHARMACEUTICALS, INC.
K770454 05/03/1977 CREATININE PROCEDURE, TEKPOINT ICN PHARMACEUTICALS, INC.
K770455 05/03/1977 GLUCOSE PROCEDURE, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770453 05/03/1977 PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE ICN PHARMACEUTICALS, INC.
K770456 05/03/1977 PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT ICN PHARMACEUTICALS, INC.
K770452 05/03/1977 PROTEIN PROCEDURE, TEKPOINT TOTAL ICN PHARMACEUTICALS, INC.
K770630 05/23/1977 ADAPTER, UNIVERSAL, BE 105-6 INSTRUMENTATION INDUSTRIES, INC.
K770627 05/23/1977 ADAPTER, VALVE, ONE WAY BE-130-22 INSTRUMENTATION INDUSTRIES, INC.
K770633 05/23/1977 BRACKET BE 122-1 INSTRUMENTATION INDUSTRIES, INC.
K770628 05/23/1977 CLAMP BE-152 INSTRUMENTATION INDUSTRIES, INC.
K770631 05/23/1977 FLEX ARM BE 122, CLAMP 122-27 INSTRUMENTATION INDUSTRIES, INC.
K770629 05/23/1977 VALVE, EXHALATION BE 115-4, 115-5 INSTRUMENTATION INDUSTRIES, INC.
K770589 05/23/1977 FILTER, INTRAVENOUS W/AUTO AIR VENT JELCO LABORATORIES
K770579 05/23/1977 CATHETER, URETHRAL PRESSURE, UPE-10 & 12 LIFE-TECH INSTRUMENTS, INC.
K770798 05/06/1977 BLADES, SURGICAL, STERILE LUKENS CORP.
K770800 05/06/1977 HANDLES, BLADE, SURGICAL LUKENS CORP.
K770794 05/06/1977 SUTURE REMOVAL SET, STERILE LUKENS CORP.
K770885 05/25/1977 HEARING AID, SERIES K-BEHIND-THE-EAR MAICO HEARING INSTRUMENTS, INC.
K770706 05/06/1977 CATHETER, IRRIGATION MALLINCKRODT CRITICAL CARE
K770836 05/26/1977 ULTIMAT L4 X L4, LIEBEL-FLARSHEIM MALLINCKRODT GROUP, INC.
K770758 05/20/1977 INJECTION SYSTEM, MDC I.V. MEDICAL DEVELOPMENT CO.
K770904 05/26/1977 PROBE, BLOOD FLOW DETECTOR PLUG-IN MEDSONICS
K770508 05/09/1977 SMAC SYSTEM MID TECH, INC.
K770659 05/20/1977 RIALYZE HPL (RIA) MILES LABORATORIES, INC.
K770390 05/03/1977 URINALYSIS PROFICIENCY MILES LABORATORIES, INC.
K770854 05/26/1977 LUTEINIZING HORMONE RIA REAGENT, LH-RIA NICHOLS INSTITUTE DIAGNOSTICS
K770506 05/06/1977 IN VITRO DIAGNOSTIC REAGENTS NORWOOD SCIENTIFIC ASSOCIATES, INC.
K770838 05/23/1977 ANESTHESIA BREATHING CIRCUIT, DISPOSABLE OHIO MEDICAL PRODUCTS
K770828 05/23/1977 NEBULIZER HEATER OHIO MEDICAL PRODUCTS
K770891 05/26/1977 SPLINH, FOREARM ORTHOPEDIC SYSTEMS, INC.
K770890 05/26/1977 SPLINT, COCKUP ORTHOPEDIC SYSTEMS, INC.
K770778 05/20/1977 MAXI-PADS, STAYFREE PERSONAL PRODUCTS CO.
K770801 05/25/1977 MICROBIO. PROD. FLUORESCENT ANTIBODY PFIZER PHARMACEUTICALS
K770855 05/26/1977 SYNERVIEW MODEL 6478 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K770879 05/25/1977 BRONCHOFIBERSCOPE, FB-19A PILLING CO.
K770785 05/20/1977 MONITOR, RESPIRATORY, TWO-GAS, RDC RESEARCH DEVELOPMENT CORP.
K770697 05/20/1977 COLPOSCOPE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K770829 05/18/1977 RECORDING UNIT, MODEL 1445 SCOLE ENGINEERING CO.
K770510 05/10/1977 CANNULA, INTRAVENOUS, TEFLON SHERWOOD MEDICAL INDUSTRIES
K770853 05/23/1977 STERILE COTTON STAT MEDICAL CORP.
K770788 05/06/1977 ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 STORZ INSTRUMENT CO.
K770592 05/20/1977 CYTOLOGY FIXATIVE SURGIPATH MEDICAL INDUSTRIES, INC.
K770812 05/23/1977 HANDLES, LIGHT, SURGICAL, STEOILE SYBRON CORP.
K770666 05/06/1977 HEMALOG 8/90 TECHNICON INSTRUMENTS CORP.
K770635 05/23/1977 PROTECTOR, HEEL & ELBOW TECNOL NEW JERSEY WOUND CARE, INC.
K761255 05/04/1977 DIGITAL THERMOMETER TEXAS INSTRUMENTS, INC.
K770845 05/26/1977 T3 UPTAKE REAGENT SET THE DOW CHEMICAL CO.
K770762 05/10/1977 BAG, URINARY, DRAINAGE, 2D9013 TRAVENOL LABORATORIES, S.A.
K770735 05/10/1977 DIALYZER, COIL, CD, LSA, 5M1765 TRAVENOL LABORATORIES, S.A.
K770734 05/10/1977 DIALYZER, FIBER, HOLLOW TRAVENOL LABORATORIES, S.A.
K770884 05/23/1977 ELHCTROCARDIOGRAPHIC CONNECTING WIRES TRONOMED, INC.
K761179 05/03/1977 PSORALITE ULTRALITE
K770768 05/06/1977 OPHTHALMOSCOPE, MODEL #11100 WELCH ALLYN, INC.
K770908 05/23/1977 PROSTHESIS, HIP, TRAPEZOIDAL-28 ZIMMER, INC.


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