FDA 510(k) Decisions During November, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K771908 11/07/1977 ISO-SHIELD SALIVA ABSORBERS 3M COMPANY
K771511 11/30/1977 TOTAL KNEE PROSTHESIS-NONCONSTRAINED 3M COMPANY
K772001 11/02/1977 SARNES HELP 3M HEALTH CARE, SARNS
K772137 11/21/1977 VEIN CLAMPS A&A ENT.
K771991 11/03/1977 CARDIAC OUTPUT THERMODILUTION MODULE ABBOTT LABORATORIES
K771669 11/09/1977 DIAG. KIT FOR TOTAL ANTITHROMBIN III ABBOTT LABORATORIES
K772036 11/16/1977 IN-LINE BURETTE SET ABBOTT LABORATORIES
K771869 11/02/1977 DIAG. ULTRASOUND B-SCANNER ACCUSONICS, INC.
K772119 11/14/1977 TIME WATCH AKZONA, INC.
K771913 11/15/1977 HEEL/ELBOW PROTECTOR ALBA-WALDENSIAN, INC.
K772046 11/23/1977 INTUBATION PROCEDURE KIT AMERICAN HOSPITAL SUPPLY CORP.
K772047 11/23/1977 RESPIRATORY KIT AMERICAN HOSPITAL SUPPLY CORP.
K771914 11/09/1977 SUBJECTIVE REFRACTOR, MOSEL SR-111 AMERICAN OPTICAL CORP.
K771980 11/02/1977 FEVER TESTER AMERICAN THERMOMETER COMPANY, INC.
K772122 11/17/1977 T3 RIA KIT ANTIBODIES INC.
K771932 11/07/1977 RECORDER, DINMAP, MODEL 950 APPLIED MEDICAL RESEARCH
K770937 11/17/1977 PUMP, BYPASS, PULSATILE, AVCO AVCO MEDICAL PRODUCTS
K771022 11/29/1977 CATHETER, UMBILICAR ARTERY AXIOM MEDICAL, INC.
K771678 11/22/1977 THROMBO-SCREEN PLATELET ADHESION BAY AREA HEMA. ONCO. CLINIC. & RES. L
K772082 11/28/1977 ENZAC URIC ACID 100-TEST KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771784 11/30/1977 IOPSY TRAY FOR SOFT TISSUE BIOPSY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771523 11/22/1977 LATELET RETENTION COLUMN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771867 11/17/1977 MYCOPLASMA DETECTION KIT BIOASSAY SYSTEMS RESEARCH CORP.
K771923 11/11/1977 FASTCHEM BUN BOEHRINGER MANNHEIM CORP.
K772152 11/28/1977 CENTRAL MONITORING SYSTEM BURDICK CORP.
K772150 11/28/1977 DIALYSIS DRAINAGE UNIT, PERITONEAL C.R. BARD, INC.
K771776 11/09/1977 ECG CLUSTER ELECTRODE C.R. BARD, INC.
K771394 11/09/1977 ELECTRONIC STETHESCOPE C.R. BARD, INC.
K771393 11/11/1977 ELHCTRONIC SPHYGMOMANOMETER C.R. BARD, INC.
K771993 11/02/1977 AFT SYSTEM CALBIOCHEM
K771639 11/29/1977 ELECTROSURGICAL GENERATOR CAMERON-MILLER, INC.
K772027 11/09/1977 CARDIOCASSETTE II CARDIODYNE, INC.
K772015 11/15/1977 PATIENT HEATER SYSTEM, MODEL PH112 CAROLINA MEDICAL ELECTRONICS
K771865 11/28/1977 DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 CASTLE CO.
K771893 11/02/1977 DISPOSABLE ELHCTRODE CHASE MEDICAL SERVICES
K772087 11/14/1977 ULTRASONIC DENTURE CLEANER CLAIROL, INC.
K771985 11/02/1977 FILTER SAMPLER BLOOD SERUM FILTER CLASROCK
K772110 11/22/1977 IN VITRO DIGOXIN RIA TEST CLINICAL ASSAYS, INC.
K772111 11/28/1977 IN VITRO PHENOBARBITAL RIA TEST CLINICAL ASSAYS, INC.
K772108 11/17/1977 IN VITRO T3 RIA TEST CLINICAL ASSAYS, INC.
K771785 11/29/1977 IRRIGATING NEEDLE, ILLUMINATED CONCEPT, INC.
K771929 11/16/1977 PEDIATRICS GOWN CONVERTORS
K771992 11/02/1977 L-501 CARDIAC PACEMAKER CORATOMIC, INC.
K772112 11/17/1977 NON-FERMENTER SYSTEM CORNING MEDICAL & SCIENTIFIC
K771512 11/09/1977 COUNTER MODEL S PLUS BLOOD CELL COUNTER COULTER ELECTRONICS, INC.
K771753 11/28/1977 HEMATOLOGY REFERENCE CONTROL COULTER ELECTRONICS, INC.
K772053 11/09/1977 LINE CHARGER MODEL LC-100 DATASCOPE CORP.
K772056 11/22/1977 PHYSIOLOGICAL MONITOR MODEL 871 DATASCOPE CORP.
K772052 11/22/1977 PHYSIOLOGICAL RECORDER MODEL 721A DATASCOPE CORP.
K772054 11/22/1977 PHYSIOLOGICAL RECORDER MODEL 740 DATASCOPE CORP.
K771969 11/02/1977 TURBO-JET MODEL 76 DAZEY PRODUCTS CO.
K771966 11/02/1977 VIBRO BATH MODEL FS-1 DAZEY PRODUCTS CO.
K771970 11/02/1977 WHIRLPOOL BATH MODEL 50 DAZEY PRODUCTS CO.
K771973 11/07/1977 GINGITRACT DEN-MAT CORP.
K772081 11/11/1977 NAIL, INTRAMEDULLARY, FLEXIBLE DEPUY, INC.
K772130 11/28/1977 OCULAR CEREBRAL VASCULAR MONITOR DIGILAB, INC.
K771548 11/07/1977 SILASTIC BRAND INTRAVAGINAL TARSETTE DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K771989 11/15/1977 CONTINUOUS FLOW ANESTHESIA MACHINE DRAEGER MEDICAL, INC.
K771924 11/28/1977 HEARTBEATER DUNN INSTRUMENTS, INC.
K772092 11/18/1977 CHEST FLUID MONITOR DYNATECH RESEARCH & DEVELOPMENT CO.
K772093 11/18/1977 IMPEDANCE RHEOGRAPH DYNATECH RESEARCH & DEVELOPMENT CO.
K771866 11/09/1977 TROUTMAN CORNEAL PUNCH EDWARD WECK, INC.
K771987 11/02/1977 MICROPULSE 26U PULSE GENERATOR EDWARDS PACEMAKER SYSTEMS
K772059 11/15/1977 CATHETER, PACING/MONITORING ELECTRO-CATHETER CORP.
K771994 11/02/1977 ELECTROTHERM MODEL HT-1 ELECTROMEDICS, INC.
K771999 11/15/1977 ELECTROTHERM MODELS F&C18,14,78, F84 ELECTROMEDICS, INC.
K771995 11/22/1977 ELECTROTHERM MODELS TC-100 & M-99 ELECTROMEDICS, INC.
K771996 11/22/1977 TELETHERMOMETER MODEL T T-100 ELECTROMEDICS, INC.
K771997 11/15/1977 TELETHERMOMETER MODEL T T-400 ELECTROMEDICS, INC.
K771998 11/15/1977 TEMP-A-LERT MODEL TA-986 ELECTROMEDICS, INC.
K771978 11/23/1977 CTR 100L EMI MEDICAL, INC.
K772125 11/21/1977 TOMOGRAPHIC SCANNER, COMPUTERIZED EMI MEDICAL, INC.
K771885 11/02/1977 IMPORTED PAIN CONTROL DEVICE EMPI
K772151 11/30/1977 URINARY VMA - SCREEN TEST KIT EPPENDORF-BRINKMANN, INC.
K771852 11/02/1977 NIMETIC POLISHING PASTE ESPE GMBH (US)
K771412 11/28/1977 LIGACLIP MULTIPLE CLIP APPLIER ETHICON, INC.
K771413 11/28/1977 LIGACLIP MULTIPLE LIGATING CLIPS ETHICON, INC.
K771619 11/15/1977 PROXIMATE DISP. SKIN STAPLER ETHICON, INC.
K772163 11/28/1977 DIALYSIS MACHINES DM-346 & 346-1 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K771955 11/22/1977 TRYPSIN 1% FLOW LABORATORIES, INC.
K771555 11/28/1977 PERITONEAL DIALYSIS CATHETER FLUORO-MOLD CO.
K771976 11/09/1977 ECG AMPLIFIER/R WAVE TRIGGER G.D. SEARLE AND CO.
K772004 11/03/1977 HUMAN C4 COMPLEMENT CONTROL SERUM G.D. SEARLE AND CO.
K772003 11/03/1977 HUMAN REFERENCE SERUM C4 COMPLEMENT G.D. SEARLE AND CO.
K772002 11/02/1977 PLATES FOR HUMAN C4 COMPLEMENT G.D. SEARLE AND CO.
K771829 11/02/1977 ALKALINE PHOSPHATASE GAMMA ENTERPRISES, INC.
K771832 11/22/1977 CHLORIDE GAMMA ENTERPRISES, INC.
K771834 11/03/1977 CREATININE GAMMA ENTERPRISES, INC.
K771835 11/02/1977 INORGANIC PHOSPHORUS GAMMA ENTERPRISES, INC.
K771836 11/22/1977 LACTATE DEHYDROGENASE GAMMA ENTERPRISES, INC.
K771837 11/02/1977 POTASSIUM GAMMA ENTERPRISES, INC.
K771838 11/03/1977 SERUM IRON GAMMA ENTERPRISES, INC.
K771839 11/02/1977 SODIUM GAMMA ENTERPRISES, INC.
K771843 11/22/1977 WETTING AGENTS GAMMA ENTERPRISES, INC.
K772089 11/11/1977 LAPAROTOMY SPOGNE GENERAL MEDICAL CO.
K772024 11/09/1977 RX LENS SERIES GENTEX CORPORATION
K771742 11/22/1977 EVOKED RESPONSE SYS., MODEL 10 GRASS INSTRUMENT CO.
K772049 11/11/1977 WALKING AID GUARDIAN PRODUCTS CO., INC.
K771928 11/14/1977 CALCIUM SET, ITEM NO. 65004 HARLECO
K772107 11/28/1977 CREATININE URINE APPLI.-#32308 HARLECO
K772029 11/15/1977 GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT HARLECO
K772032 11/17/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP HARLECO
K772033 11/17/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* HARLECO
K772034 11/17/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 HARLECO
K772030 11/14/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT HARLECO
K772028 11/15/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH HARLECO
K772035 11/17/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL HARLECO
K772031 11/14/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT HARLECO
K771927 11/14/1977 IRON SET, ITEM NO. 65008 HARLECO
K771925 11/02/1977 KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP HARLECO
K771926 11/11/1977 TOTAL PROTEIN SET, ITEM NO. 64010 HARLECO
K772132 11/22/1977 AMPLIFIER MODULE, 78211A ECG HEWLETT-PACKARD CO.
K771380 11/03/1977 ELAPSED TIME INDICATOR MODEL 21361A HEWLETT-PACKARD CO.
K772048 11/09/1977 SINGLE & DUAL CHANNEL RECORDER HEWLETT-PACKARD CO.
K772102 11/21/1977 AMPLIFIER OTRONA, MODEL N3A-EMG HONEYWELL, INC.
K772012 11/07/1977 VIDEO ADAPTER FOR GRAPHIC RECORDERS HONEYWELL, INC.
K771881 11/09/1977 REPLICA BONDING AGENT HOYT LABORATORIES
K771795 11/14/1977 LAS-R CERULOPLASMIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771700 11/11/1977 TMA BICARBONATE/GLYCEROL DILUENT HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K772114 11/30/1977 FIAX C4 ASSAY IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS
K772072 11/15/1977 MANIFOLD & NEBU. FOR DOUB. LINE MACH. INSPIRON CORP.
K772071 11/15/1977 MANIFOLD & NEBU. FOR SINGLE LINE MACH. INSPIRON CORP.
K772068 11/15/1977 MANIFOLD & NEBULIZER, UNIVERSAL INSPIRON CORP.
K772070 11/15/1977 VENTILATOR SETUP, VOLUME INSPIRON CORP.
K772069 11/15/1977 VOL. VENTILATOR SETUP W/OUT NEBULIZER INSPIRON CORP.
K771922 11/02/1977 MINICLINIC TM INSTROMEDIX, INC.
K772057 11/03/1977 BIPOLAR PACEMAKER MODEL 224 INTERMEDICS, INC.
K771153 11/03/1977 DYNA ZYME II GOT 340 J.T. BAKER CHEMICAL CO.
K771152 11/03/1977 DYNAZYME II GPT 340 J.T. BAKER CHEMICAL CO.
K771847 11/02/1977 TEMP-TESTER JABLECKI, CHARLES, DR.
K772154 11/30/1977 CERVICAL TRACTION DIV., PNEUMATIC JOBST
K772020 11/02/1977 CLOTH ADHESIVE TAPE JOHNSON & JOHNSON PROFESSIONALS, INC.
K772128 11/22/1977 FLUORESCEIN CONJUGATED KALLESTAD LABORATORIES, INC.
K772134 11/28/1977 SYRINGE, IRRIGATION, PRE-FILLED KENDALL RESEARCH CENTER
K772133 11/28/1977 URINE SPECIMEN COLLECTING DEVICE KENDALL RESEARCH CENTER
K771962 11/21/1977 CAMERA ADAPTER FOR ENDOSCOPES KLI
K772185 11/30/1977 LAPAROSCOPE W/REMOVABLE OPTICS KLI
K771849 11/03/1977 CPK COLOR TEST KIT MALLINCKRODT CRITICAL CARE
K772064 11/14/1977 THYRODOT-4 ANTISERA LYOPHOLIZED MEDCOM DIAGNOSTICS, INC.
K772144 11/28/1977 CATHETER, DISP., EXTERNAL, MALE MEDLINE INDUSTRIES, INC.
K772062 11/15/1977 NEONATAL FLOTATION SYSTEM MEDPRO, INC.
K772103 11/21/1977 BIPOLAR LEADS, DISP. MEDTRONIC VASCULAR
K772058 11/03/1977 LEAD ADAPTOR KIT MODEL 5866-21 MEDTRONIC VASCULAR
K772104 11/28/1977 PACING LEAD MODEL 6991A MEDTRONIC VASCULAR
K772000 11/22/1977 ECG TELEMETRY SYSTEM MENNEN GREATBATCH ELECTONICS
K772005 11/23/1977 MYOTONE EMG MONITOR MICROTRONICS CORP.
K772014 11/02/1977 AMES T-4 STRIP TEST MILES LABORATORIES, INC.
K772039 11/23/1977 BETA-HCG RIA MONITOR SCIENCE CORP.
K771921 11/15/1977 HYDRON ROOT CANAL FILLING SYSTEM NATIONAL PATENT DEVELOPMENT CORP.
K772160 11/28/1977 ELECTROSURGICAL GROUNDING PAD NDM CORP.
K772065 11/28/1977 CRITICAL CARE VENTILATOR 2 OHIO MEDICAL PRODUCTS
K771479 11/07/1977 NITROX 30 - ANESTHETIC GAS PROPORTIONER OHIO MEDICAL PRODUCTS
K771990 11/30/1977 OMNIMEDICAL 400L OMNIMEDICAL SERVICES, INC.
K772086 11/23/1977 QUANTROLS HCG ORGANON, INC.
K771941 11/02/1977 QUANTROLS IM ORGANON, INC.
K771940 11/02/1977 QUANTROLS RF ORGANON, INC.
K771487 11/08/1977 LEWIS BLOOD GROUP SUBSTANCE ORTHO DIAGNOSTICS, INC.
K771488 11/08/1977 P1 BLOOD GROUP SUBSTANCE ORTHO DIAGNOSTICS, INC.
K771814 11/07/1977 REAGENT CONFIDENCE SERA ORTHO DIAGNOSTICS, INC.
K772096 11/22/1977 IN VITRO DIAGNOSTIC REAGENT PCL-RIA, INC.
K771810 11/17/1977 PRESSURE TUBING PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K772123 11/21/1977 TOMOGRAPHIC SYSTEM, COMPUTERIZED PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K772023 11/18/1977 OB/GYN LASER, MODEL 920 PHOTON SOURCES
K772006 11/28/1977 ACUTE CARDIAC CARE SYSTEM PHYSIO-CONTROL CORP.
K771723 11/22/1977 HILL TUBE PHYSIO-CONTROL CORP.
K771265 11/22/1977 PRESSURE MONITOR MANOMETRIC SYS. PHYSIO-CONTROL CORP.
K772055 11/15/1977 PENTAX F.O.-IT OBSERVER SCOPE PILLING CO.
K771420 11/28/1977 BETA-CAP QUINTON, INC.
K771483 11/28/1977 CATHETER FINGER GRIP QUINTON, INC.
K772097 11/22/1977 HEARTRATE METER MODEL 650, P/N 000119 QUINTON, INC.
K772168 11/30/1977 MOLDEYE ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
K772149 11/22/1977 LANCER BIOPSY HOLDER SHERWOOD MEDICAL INDUSTRIES
K771720 11/03/1977 AMIDO BLACK CONCENTRATE SIGMA CHEMICAL CO.
K772121 11/17/1977 ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. SMITH KLINE DIAGNOSTICS, INC.
K772148 11/29/1977 CATHETER, FEMORAL VEIN, SF 6 SORENSEN RESEARCH
K772146 11/29/1977 CATHETER, VEIN, FEMORAL, SF 10 SORENSEN RESEARCH
K772147 11/28/1977 GW 35 GUIDE WIRE SORENSEN RESEARCH
K771856 11/03/1977 DIR. QUANT. COLOR. DETERM. SERUM CREAT. STANBIO LABORATORY
K772043 11/28/1977 ALPHA/CHOL STANDARD SCIENTIFIC, INC.
K772100 11/21/1977 HEARING AID-MODEL CE-2 STARKEY LABORATORIES, INC.
K772101 11/21/1977 HEARING AID-MODEL PE-1 STARKEY LABORATORIES, INC.
K771680 11/28/1977 ARMOR-KOT SURGICAL INSTRUMENTS STORZ INSTRUMENT CO.
K772105 11/30/1977 PLATELET KIT STRECK LABORATORIES, INC.
K772167 11/22/1977 EMIT LIDOCAINE CONTROL SYVA CO.
K772166 11/22/1977 EMIT THEOPHYLLINE CONTROL SYVA CO.
K771728 11/07/1977 AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 TECHNICON INSTRUMENTS CORP.
K771821 11/07/1977 STAC SYSTEM TECHNICON INSTRUMENTS CORP.
K771939 11/03/1977 STAC SYSTEM-ADDI. ANALYTES TECHNICON INSTRUMENTS CORP.
K772124 11/16/1977 LENSES, EYEGLASS, SAFETY TECHSIGHT CORP.
K772044 11/09/1977 TECHSIGHT LENSES WITH ZUMA COATING TECHSIGHT CORP.
K772026 11/03/1977 CARDIAC PULSE GENERATOR, MODEL 150L TELECTRONICS, INC.
K772040 11/28/1977 TRANSDUCER PROTECTOR TERUMO AMERICA, INC.
K771102 11/22/1977 UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS THE DOW CHEMICAL CO.
K771938 11/02/1977 ALGINATE IMPRESSION MATERIAL THE S. S. WHITE CO.
K771861 11/28/1977 CATHETER, CEBTRAL VENOUS, 2N1501 TRAVENOL LABORATORIES, S.A.
K771891 11/02/1977 CATHETER, UMBILICAL, VICRA TRAVENOL LABORATORIES, S.A.
K771875 11/30/1977 ULTRAFILTRATION MONITOR 5M9034 TRAVENOL LABORATORIES, S.A.
K772113 11/16/1977 URINARY DRAINAGE BAG 2D9017 TRAVENOL LABORATORIES, S.A.
K771979 11/17/1977 CENTRIA INSULIN RIA UNION CARBIDE CORP.
K771982 11/02/1977 888 ARTERIAL/VENOUS CATHETER INTRODUCER USCI, DIV. C.R. BARD, INC.
K772021 11/02/1977 TRC STAINLESS STEEL SAFETY SPRING GUIDES USCI, DIV. C.R. BARD, INC.
K772158 11/22/1977 LIGHT-PEN SYSTEM FOR QUANTI. ANALY. VARIAN ASSOC., INC.
K772165 11/28/1977 SPECTROPHOTOMETER - SERIES AA-575 VARIAN ASSOC., INC.
K771807 11/28/1977 SPECTROPHOTOMETER ANALYSIS SYS. VARIAN ASSOC., INC.
K772022 11/11/1977 SPECTROPHOTOMETER CARY 219 VARIAN ASSOC., INC.
K772175 11/28/1977 CATHETER SYSTEM, COPE/EISENBERG VICTORY ENGINEERING CORP.
K772010 11/28/1977 CARDIAC PACEMAKER C2001 VITATRON MEDICAL BV
K772009 11/28/1977 CARDIAC PACEMAKER S6001 VITATRON MEDICAL BV
K771900 11/09/1977 71110 DESK CHARGER WELCH ALLYN, INC.
K771864 11/22/1977 WALL TRANSFORMERS 74710 & 74910 WELCH ALLYN, INC.
K771793 11/02/1977 DHEA TEST SET WIEN LABORATORIES, INC.
K771886 11/14/1977 ACCU-PAQUE WILLIAMS GOLD REFINING CO., INC.
K771887 11/14/1977 ACCU-STAIN WILLIAMS GOLD REFINING CO., INC.
K771660 11/07/1977 KWICK KOOLER WORLD TRADE ASSOC.
K772025 11/11/1977 URIC ACID STD. FOR QUANT. URIC ACID WORTHINGTON BIOCHEMICAL CORP.


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