FDA 510(k) Applications Received During May, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K770822 05/04/1977 A-GENT ALBUMIN ABBOTT LABORATORIES
K770868 05/12/1977 CATHETER, POLYURETHANE, W/STYLET ABBOTT LABORATORIES
K770843 05/09/1977 IV PUMP FILTERSET, UNIVERSAL ABBOTT LABORATORIES
K770865 05/11/1977 MONITOR, PACEMAKER ADCOR ELECTRONICS, INC.
K770861 05/09/1977 SURGICAL COLDLIGHT, AX8 AFFILIATED HOSPITAL PRODUCTS, INC.
K770873 05/13/1977 CIRCUMCISION KIT AMERICAN HOSPITAL SUPPLY CORP.
K770909 05/19/1977 ENZYMATIC CHOLESTEROL REAGENT SET AMERICAN MONITOR CORP.
K770824 05/04/1977 FLAME PHOTOMETER MOLEL 4600, KDA AMERICAN MONITOR CORP.
K770989 05/31/1977 API 50 E ANALYTICAL PRODUCTS, INC.
K770926 05/10/1977 SUSPENSION SALINE, API 20E ANALYTICAL PRODUCTS, INC.
K770813 05/03/1977 ENDOGATOR AUS-TEX DENTAL MFG. & DESIGN
K770823 05/04/1977 AUDIOMETRIC TESTING SYS., SERIES 500 AUTOMATED TESTING SERVICES, LTD.
K770821 05/04/1977 PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT AVCO MEDICAL PRODUCTS
K770937 05/23/1977 PUMP, BYPASS, PULSATILE, AVCO AVCO MEDICAL PRODUCTS
K770983 05/31/1977 CATHETER THORACIC, AXIOM AXIOM MEDICAL, INC.
K770980 05/31/1977 EMATOLOGY DILUENT RESERVOIR CLOSURE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770877 05/16/1977 DATA REDUCTION SYSTEM, DP-3000 BECKMAN INSTRUMENTS, INC.
K770948 05/25/1977 LIPOPROTEIN PROFILING SYSTEM BECKMAN INSTRUMENTS, INC.
K770825 05/05/1977 SPECTROPHOTOMETERS,34,35,36,3600 BECKMAN INSTRUMENTS, INC.
K770790 05/02/1977 FEEDBACK EDR SYSTEM MODEL EDR-100 BIO-FEEDBACK SYSTEMS, INC.
K770921 05/20/1977 SPHYGMOMANOMETER, ELECTRONIC BRISTOLINE, INC.
K770939 05/23/1977 URINE TESTER, MODEL 701 BROTHER SCIENTIFIC PRODUCTS, INC.
K770814 05/03/1977 CATHETER, URETHERAL C.R. BARD, INC.
K770943 05/25/1977 ENDOSCOPE, UROLOGICAL, FEMALE C.R. BARD, INC.
K770881 05/16/1977 GENERATOR, PULSE, BIPOLAR 3608 CARDIAC PACEMAKERS, INC.
K770880 05/16/1977 GENERATOR, PULSE, UNIPOLAR, #508 CARDIAC PACEMAKERS, INC.
K770988 05/31/1977 FOAM ECG ELECTRODE, 2060 AND 2061 CARDIO-DYNAMICS LABORATORIES, INC.
K770953 05/25/1977 MONITOR, AERATION, TEC-TEST CASTLE CO.
K770969 05/31/1977 CLEV-DENT COLHS ELECTROSURG, MOLEL TR-5 CAVITRON CORP.
K770968 05/31/1977 MONITOR, PATIENT, MODEL PM-I0N CAVITRON CORP.
K770866 05/11/1977 RABBIT COMPLEMENT CEDARLAKE LABS LTD.
K770900 05/16/1977 CAST BRWM, FRACTURE CHASE MFG. CO.
K770898 05/16/1977 FRACTURE CAST BRACE KIT, PLASTIC CHASE MFG. CO.
K770899 05/16/1977 FRACTURE CAST BRACE, POLY CHASE MFG. CO.
K770789 05/03/1977 URI-DRAIN COMBO KIT FOR MALE INCONTINENC CHESEBROUGH-POND'S U.S.A. CO.
K770857 05/09/1977 DIALYSIS MACHINE, CENTRY II COBE LABORATORIES, INC.
K770867 05/12/1977 DIALYZER, FIBER, HOLLOW COBE LABORATORIES, INC.
K770852 05/09/1977 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 CONCORD LABORATORIES, INC.
K770851 05/09/1977 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 CONCORD LABORATORIES, INC.
K770850 05/09/1977 TRAY, BLOOD GAS, ARTERIAL, #4014 CONCORD LABORATORIES, INC.
K770933 05/23/1977 BIO-SHIELD CSR WRAP CONVERTORS
K770913 05/19/1977 UROLOGICAL BIOPSY BRUSH SET COOK, INC.
K770951 05/25/1977 CARDIAC PACERS W/NARROW PULSE WIDTH CORDIS CORP.
K770792 05/02/1977 TUBE, STAIN, RETICULOCYTE, LARC CORNING MEDICAL & SCIENTIFIC
K770787 05/02/1977 RELAXATION COURSE MOLEL 1000 CYBERNETIC MEDICAL, INC.
K770973 05/31/1977 CARDIOZYME CK CONTROL NORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770971 05/31/1977 CARDIOZYME CK-CONTROL ABNORMAL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770974 05/31/1977 CARDIOZYME CK-MB REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770972 05/31/1977 CARDIOZYME CK-TOTAL REAGENTS DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770950 05/25/1977 WHOLE BLOOD GAS CONTROL DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K770918 05/19/1977 LIQUI SOL T4 RIA TEST KIT DAMON CORP.
K770856 05/09/1977 PROSTHESIS, TRAPEZIUM & TRAPEZIUM TRIAL DEPUY, INC.
K770786 05/02/1977 SPLINTS, FINGER/TOE DEPUY, INC.
K770862 05/10/1977 BLACK LAMPS,F72T12/BL/HO DERMATRON CORP.
K770896 05/16/1977 COLPOSCOPE MODEL II DYNATECH CRYOMEDICAL CO.
K770986 05/31/1977 FLEXI-THERM FILM E-Z-EM, INC.
K770915 05/19/1977 CLASP RIA KIT, HTSH E. R. SQUIBB & SONS, INC.
K770919 05/19/1977 PHENOBARBITAL ANALYTICAL TEST PACKS E.I. DUPONT DE NEMOURS & CO., INC.
K770837 05/06/1977 SCREEN, FINE, LANES, KODAK EASTMAN KODAK COMPANY
K770791 05/02/1977 DEPILATOR, DERMA-I & DERMA-II ELECTRO-KINETIC ENG/MFG
K770782 05/02/1977 FIBERSCOPIC SCOPE RECORDER SYSTEM ELMED, INC.
K770941 05/23/1977 APPLIC SYSTEM ACTIVATOR, ESPE ESPE GMBH (US)
K770931 05/23/1977 APPLIC SYSTEM APPLIER, ESPE ESPE GMBH (US)
K770922 05/20/1977 DENTAL RESTORATIVE IN CAPSULES ESPE GMBH (US)
K770923 05/20/1977 ESPETEMP (TEMP. CEMENT) ESPE GMBH (US)
K770872 05/13/1977 IMPRESSION MATERIAL, ALGINATE ESPE GMBH (US)
K770990 05/31/1977 DENTAL PLAQUE DISCLOSING AGENT EVIDENT DENTAL CO. LTD.
K770811 05/03/1977 ADENOVIRUS GROUP-FA LABELLED PRESERUM FLOW LABORATORIES, INC.
K770807 05/03/1977 ADENOVIRUS-GROUP FA LABELLED (8-651 RF) FLOW LABORATORIES, INC.
K770809 05/03/1977 MEASLES-FA LABELED PRESERUM (8-441 RNF) FLOW LABORATORIES, INC.
K770805 05/03/1977 MEASLES-FA LABELLED (8-441 RF) FLOW LABORATORIES, INC.
K770808 05/03/1977 RESP. SYNCYTIAL-FA LABELLED PRESERUM FLOW LABORATORIES, INC.
K770804 05/03/1977 RESP. SYNCYTIAL-FA LABELLHD (8-301-RF) FLOW LABORATORIES, INC.
K770810 05/03/1977 VARICELLA-ZOSTER FA LABELED PRESERUM FLOW LABORATORIES, INC.
K770806 05/03/1977 VARICELLA-ZOSTER FA LABELLED (8-321 RF) FLOW LABORATORIES, INC.
K770910 05/19/1977 MEDISHIELD CERVICAL COLLAR FRASER SWEATMAN, INC.
K770911 05/19/1977 MEDISHIELD JORDON LIFTING FRAME FRASER SWEATMAN, INC.
K770858 05/09/1977 DIALYZER, ULTRADIFFUSER, DISPOSABLE GAMBRO, INC.
K770783 05/02/1977 FILM PROCESSOR, AUTOMATIC GENERAL ELECTRIC CO.
K770869 05/13/1977 ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K770957 05/27/1977 PEDIATRIC BLOOD CULTURE BOTTLES GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770840 05/09/1977 PRE-REDUCED ANAEROBIC MEDIA GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K770839 05/09/1977 AQUAMATIC K-77 GORMAN RUPP INDUSTRIES
K770875 05/16/1977 IMPROVED THAYER MARTIN (JEMBEC) GRANITE DIAGNOSTICS, INC.
K770874 05/16/1977 IMPROVED THAYER MARTIN (PLATE) GRANITE DIAGNOSTICS, INC.
K770876 05/16/1977 IMPROVED TRANSGROW GRANITE DIAGNOSTICS, INC.
K770944 05/25/1977 INSTATEMP H.I. SILVERMAN, D.SC.
K770956 05/27/1977 PAS ANTI-EMBOLISM SYSTEM HAMILTON INDUSTRIES, INC.
K770928 05/20/1977 PART NO. 66-00121 HARLAKE CYPRANE
K770927 05/20/1977 PART NO. 66-00311 HARLAKE CYPRANE
K770887 05/16/1977 AUTO TOTAL PROTEIN FOR ANALYZER HARLECO
K770886 05/16/1977 AUTO-ENZYMATIC GLUCOSE FOR ANALYZER HARLECO
K770816 05/04/1977 ULTRACHEM ALBUMIN HARLECO
K770817 05/04/1977 ULTRACHEM CALCIUM HARLECO
K770819 05/04/1977 ULTRACHEM CREATININE HARLECO
K770820 05/04/1977 ULTRACHEM INORGANIC PHOSPHORUS HARLECO
K770870 05/13/1977 ULTRAZYME PLUS ALP HARLECO
K770883 05/16/1977 ULTRAZYME PLUS GOT HARLECO
K770882 05/16/1977 ULTRAZYME PLUS GPT HARLECO
K770815 05/04/1977 ULTRAZYME PLUS GT HARLECO
K770871 05/13/1977 ULTRAZYME PLUS HBD HARLECO
K770818 05/04/1977 ULTRAZYME PLUS, LDH HARLECO
K770830 05/06/1977 PLATELET AGITATOR HELMER LABS, INC.
K770966 05/27/1977 INTERNAL ECOLOGY MACHINE HOLISTIC EQUIPMENT, INC.
K770826 05/05/1977 POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE HOWMEDICA CORP.
K770982 05/31/1977 UNITED SKIN BARRIER HOWMEDICA CORP.
K770803 05/02/1977 HEMOTOLOGY PRODU&TS (5 IN ALL) HYCEL, INC.
K770894 05/16/1977 NEURO-SORB PATTIES INSTRANETICS, INC.
K770946 05/23/1977 RECORD, MODEL 702, I.L. INSTRUMENTATION LABORATORY CO.
K770929 05/23/1977 BANDAGES, SPEC. X-TRA HARD OR PLASTER JOHNSON & JOHNSON PROFESSIONALS, INC.
K770932 05/23/1977 GERAMCO LOW TEMP GLAZE JOHNSON & JOHNSON PROFESSIONALS, INC.
K770964 05/27/1977 GOAT ANTISERUM COMPLEMENT C3 NEPHEL. KALLESTAD LABORATORIES, INC.
K770962 05/27/1977 GOAT ANTISERUM IGA NEPHELOMETRIC KALLESTAD LABORATORIES, INC.
K770961 05/27/1977 GOAT ANTISERUM IGG NEPHELOMETRIC KALLESTAD LABORATORIES, INC.
K770963 05/27/1977 GOAT ANTISERUM IGM NEPHELOMHTRIC KALLESTAD LABORATORIES, INC.
K770965 05/27/1977 HUMAN REFERENCE SERUM KALLESTAD LABORATORIES, INC.
K770892 05/17/1977 TSH RADIOIMMUNOASSAY KALLESTAD LABORATORIES, INC.
K770924 05/20/1977 GREEN RADIOPAQUE IN SURG. SPONGES KENDALL RESEARCH CENTER
K770977 05/31/1977 CARDIOVASCULAR SPRING GUIDES LAKE REGION MFG., INC.
K770975 05/31/1977 ANTI-CONVULSANT DRUG CONTROL LEDERLE LABORATORIES
K770897 05/16/1977 URODYNAMIC INSTRUMENTS LIFE-TECH INSTRUMENTS, INC.
K770798 05/02/1977 BLADES, SURGICAL, STERILE LUKENS CORP.
K770800 05/02/1977 HANDLES, BLADE, SURGICAL LUKENS CORP.
K770795 05/02/1977 SHAVE PREP SET LUKENS CORP.
K770796 05/02/1977 SKIN SCRUB PREP SET LUKENS CORP.
K770794 05/02/1977 SUTURE REMOVAL SET, STERILE LUKENS CORP.
K770797 05/02/1977 TRAY, CATHETERIZATION W/FOLEY, STERILE LUKENS CORP.
K770799 05/02/1977 TRAY, IRRIGATION, STERILE, BASIC LUKENS CORP.
K770955 05/27/1977 MIRACLELENS M.R.M. OPTICS, INC.
K770885 05/16/1977 HEARING AID, SERIES K-BEHIND-THE-EAR MAICO HEARING INSTRUMENTS, INC.
K770960 05/27/1977 HEARING AID, SERIES R MAICO HEARING INSTRUMENTS, INC.
K770844 05/09/1977 FLUCOSE U.V. TEST KIT MALLINCKRODT CRITICAL CARE
K770836 05/06/1977 ULTIMAT L4 X L4, LIEBEL-FLARSHEIM MALLINCKRODT GROUP, INC.
K770945 05/25/1977 POUCH, TYVEK-POLYMYLON MEDICAL DISPOSABLES INTL., INC.
K770888 05/16/1977 POMERANTZEFF EQUATOR PLUS CAMERA MEDICAL INSTRUMENT RESEARCH ASSOC., INC.
K770878 05/12/1977 SIGNAL PROCESSOR/AVERAGER MODEL 7S11 MEDICAL SYSTEMS CORP.
K770904 05/16/1977 PROBE, BLOOD FLOW DETECTOR PLUG-IN MEDSONICS
K770832 05/06/1977 PORTASCOPE II MENNEN GREATBATCH ELECTONICS
K770925 05/20/1977 IMPROVED THAYER-MARTIN MEDIUM MICRO-TECH DIAGNOSTIC, INC.
K770984 05/31/1977 TA-2 TEMPERATURE ALARM MISTOGEN EQUIPMENT CO.
K770967 05/31/1977 SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE NATIONAL PATENT DEVELOPMENT CORP.
K770854 05/09/1977 LUTEINIZING HORMONE RIA REAGENT, LH-RIA NICHOLS INSTITUTE DIAGNOSTICS
K770916 05/19/1977 TYGON PAC-MONITORING LINES & FLUID ADMIN NORTON PERFORMANCE PLASTICS CORP.
K770838 05/09/1977 ANESTHESIA BREATHING CIRCUIT, DISPOSABLE OHIO MEDICAL PRODUCTS
K770828 05/06/1977 NEBULIZER HEATER OHIO MEDICAL PRODUCTS
K770891 05/16/1977 SPLINH, FOREARM ORTHOPEDIC SYSTEMS, INC.
K770890 05/16/1977 SPLINT, COCKUP ORTHOPEDIC SYSTEMS, INC.
K770987 05/31/1977 NERVE STIMULATOR, MOLEL NO. FB-800 OUTPUT, INC.
K770970 05/31/1977 HAIR TRANSPLANT PUNCH, MULTIPLH PADGETT INSTRUMENTS, INC.
K770801 05/02/1977 MICROBIO. PROD. FLUORESCENT ANTIBODY PFIZER PHARMACEUTICALS
K770833 05/06/1977 FLUORETEC-M PFIZER, INC.
K770942 05/24/1977 PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770855 05/09/1977 SYNERVIEW MODEL 6478 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K770879 05/16/1977 BRONCHOFIBERSCOPE, FB-19A PILLING CO.
K770785 05/02/1977 MONITOR, RESPIRATORY, TWO-GAS, RDC RESEARCH DEVELOPMENT CORP.
K770829 05/05/1977 RECORDING UNIT, MODEL 1445 SCOLE ENGINEERING CO.
K770958 05/27/1977 BANDAGE, UNIPRESS, CLARION SHERWOOD MEDICAL INDUSTRIES
K770981 05/31/1977 LANCER CAPILLARY BLOOD SERUM SEPARATOR SHERWOOD MEDICAL INDUSTRIES
K770920 05/20/1977 THORACIC DRAINAGE SET, ARGYLE DUAL SHERWOOD MEDICAL INDUSTRIES
K770902 05/16/1977 COLORIMETRIC DETERM. SOCITRATE DEHYDRO. SIGMA CHEMICAL CO.
K770849 05/09/1977 VOLUMET INFUSION PUMP, MODIFI. OF SIGMAMOTOR, INC.
K770848 05/09/1977 DAILY-WEIGHT SR INSTRUMENTS, INC.
K770847 05/09/1977 PORTA-SCALE SR INSTRUMENTS, INC.
K770853 05/09/1977 STERILE COTTON STAT MEDICAL CORP.
K770788 05/02/1977 ECHOENCEPHALOGRAPH, DIGITAL,DIGIECHO2000 STORZ INSTRUMENT CO.
K770812 05/03/1977 HANDLES, LIGHT, SURGICAL, STEOILE SYBRON CORP.
K770917 05/19/1977 GLUTAMATE OXALACETIC TRANSAMINASE THE DOW CHEMICAL CO.
K770845 05/09/1977 T3 UPTAKE REAGENT SET THE DOW CHEMICAL CO.
K770940 05/24/1977 TOTAL THYROXINE (RIA) REAGENT SET THE DOW CHEMICAL CO.
K770949 05/25/1977 COMPUTER ECG TELE. TRANSMISSION TERMINAL THE OKUN CO.
K770889 05/16/1977 BURN DRESSING KIT THE OWENBY CO.
K770914 05/19/1977 INCUBATOR, PORTABLE, ACT-STAT THERMOLYNE CORP.
K770907 05/18/1977 SPIROMETEO EXHAUST TIMETER INSTRUMENT CORP.
K770912 05/16/1977 TIPROTECTOR TOWER PRODUCTS, INC.
K770884 05/16/1977 ELHCTROCARDIOGRAPHIC CONNECTING WIRES TRONOMED, INC.
K770841 05/09/1977 TRIGLYCERIDE ENZYMATIC METHOD UNION CARBIDE CORP.
K770954 05/25/1977 UNIVUE I UNION CARBIDE CORP.
K770835 05/06/1977 PATCH FABRIC USCI, DIV. C.R. BARD, INC.
K770959 05/27/1977 BOUGIE, FILIFORM, JACKSON V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K770827 05/05/1977 CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500 VARIAN ASSOC., INC.
K770863 05/11/1977 FLU VEN 0160 VENOSPITAL, INC.
K770864 05/11/1977 HEMODIALYSIS FISTULA SET VENOSPITAL, INC.
K770938 05/23/1977 TINNITUS AID, MODEL S244 VICON INSTRUMENT CO.
K770906 05/18/1977 ANOSCOPE, OPTIC, FIBER WELCH ALLYN, INC.
K770831 05/06/1977 STATZYME URIC ACID REAGENT WORTHINGTON BIOCHEMICAL CORP.
K770908 05/17/1977 PROSTHESIS, HIP, TRAPEZOIDAL-28 ZIMMER, INC.


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