FDA 510(k) Decisions During October, 1977  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K771819 10/21/1977 CABG RINGS A&A ENT.
K771858 10/20/1977 EXPAND. RETENTION ENDOSSEOUS IMPLANT A.L. MILLER, INC.
K771942 10/27/1977 TILT 10, CATALOG #S-2600 AFFILIATED HOSPITAL PRODUCTS, INC.
K771915 10/21/1977 MICRO OSCILLATING SAW AMERICAN STERILIZER CO.
K771877 10/21/1977 DIGOXIN RIA KIT ANTIBODIES INC.
K771895 10/25/1977 DINAMAP MADEL 845 APPLIED MEDICAL RESEARCH
K771772 10/04/1977 DINAMAP MODEL 825A APPLIED MEDICAL RESEARCH
K771896 10/25/1977 DINAMAP MODEL 835 APPLIED MEDICAL RESEARCH
K771897 10/25/1977 DINAMAP MODEL 837 APPLIED MEDICAL RESEARCH
K771782 10/04/1977 DINIMAP MODEL 827A APPLIED MEDICAL RESEARCH
K771931 10/27/1977 MONITOR, DINMAP, MODEL 850 APPLIED MEDICAL RESEARCH
K771638 10/07/1977 IGOXIN SOLID PHASE RIA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771796 10/18/1977 RUBA-NOST TEST KITS BEHRING DIAGNOSTICS, INC.
K771758 10/13/1977 ELASTOMULL GAUZE BANDAGE BEIERSDORF, INC.
K771496 10/25/1977 CHEMCODE/CHEMTEK SYSTEM BOEHRINGER MANNHEIM CORP.
K771825 10/06/1977 CARBA LINGUARDUC C.R. BARD, INC.
K770814 10/18/1977 CATHETER, URETHERAL C.R. BARD, INC.
K771352 10/25/1977 ELECTROSURG. PATIENT GROUNDING PLATE C.R. BARD, INC.
K770943 10/18/1977 ENDOSCOPE, UROLOGICAL, FEMALE C.R. BARD, INC.
K771025 10/25/1977 PHOTOTHERAPY/PROCEDURE LAMP CAVITRON CORP.
K771792 10/20/1977 ENEMA SET CHASE MFG. CO.
K771791 10/04/1977 NEEDLE COUNTING CHASE MFG. CO.
K771890 10/20/1977 PERCEPTION SERIES DELIVERY SYS. CHAYES VIRGINIA, INC.
K771873 10/25/1977 VISION SERIES DENTAL CHAIR CHAYES VIRGINIA, INC.
K770789 10/18/1977 URI-DRAIN COMBO KIT FOR MALE INCONTINENC CHESEBROUGH-POND'S U.S.A. CO.
K771878 10/27/1977 IRIDIUM 192 WIRES & PINS CIS RADIOPHARMACEUTICALS, INC.
K771813 10/25/1977 CENTRIFICHEM SYS 400 ANALYZER CLINICAL DIAGNOSTICS, INC.
K770857 10/04/1977 DIALYSIS MACHINE, CENTRY II COBE LABORATORIES, INC.
K771692 10/04/1977 TUBING SETS COBE LABORATORIES, INC.
K771667 10/13/1977 BLOOD GAS TRAY #4024 CONCORD LABORATORIES, INC.
K771855 10/07/1977 OMNICOR PROGRAMMER MODEL 222A CORDIS CORP.
K771610 10/07/1977 CARBON DIOXIDE ANALYZER CORNING MEDICAL & SCIENTIFIC
K771322 10/18/1977 ELECTROPHORESIS POWER SUPPLY TESTER CORNING MEDICAL & SCIENTIFIC
K771740 10/19/1977 CARDIOZYME CK-CONTROL LEVEL 1 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771971 10/21/1977 HYDROMASSAGE EQUIP. MODEL 1000 DAZEY PRODUCTS CO.
K771967 10/28/1977 WHIRLPOOL BATH MODEL 2270 DAZEY PRODUCTS CO.
K771968 10/28/1977 WHIRLPOOL BATH MODEL 2273 DAZEY PRODUCTS CO.
K771708 10/06/1977 WORRELL PATELLA DEPUY, INC.
K771710 10/06/1977 WORRELL PATELLA TEMPLATE DEPUY, INC.
K771709 10/06/1977 WORRELL TRIAL PATELLA DEPUY, INC.
K771124 10/28/1977 INSTRUMENT TRAY PAD DEVON INDUSTRIES, INC.
K771123 10/28/1977 SURGICAL INSTRUMENT PROTECTOR DEVON INDUSTRIES, INC.
K771525 10/14/1977 125 I DIGOXIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K771158 10/13/1977 ID BRACLETS, ADULT & INFANT DIVERS-A-MED
K771965 10/28/1977 WHIRLPOOL BATH MODEL 2274 DOZEY PRODUCTS CO.
K771899 10/18/1977 VAPOR 19 DRAEGER MEDICAL, INC.
K771898 10/18/1977 AUTOMATED SLIDE SPINNER DYNATECH CRYOMEDICAL CO.
K771815 10/07/1977 SIGMOSCOPE DYNATECH CRYOMEDICAL CO.
K771799 10/04/1977 ACA ALCOHOL CALIBRATORS E.I. DUPONT DE NEMOURS & CO., INC.
K771804 10/25/1977 ACA AMMONIA CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771798 10/28/1977 ACA BILIRUBIN CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771801 10/25/1977 ACA CARBON DIOXIDE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771800 10/25/1977 ACA GLUTAMYL TRANSFERASE E.I. DUPONT DE NEMOURS & CO., INC.
K771802 10/25/1977 ACA IRON CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771803 10/25/1977 ACA PHOSPHORUS CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771805 10/04/1977 ACA SALICYLATE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771797 10/25/1977 ACA TRIGLYCERIDE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771857 10/19/1977 AUTOMIXER, KODAK EASTMAN KODAK COMPANY
K771245 10/07/1977 MODEL 2/2 ANALYZER EASTMAN KODAK COMPANY
K771859 10/04/1977 NEEDLE HOLDER, MICROVASCULAR EDWARD WECK, INC.
K771376 10/18/1977 IFA ANTI-NDNA ELECTRO-NUCLEONICS LABORATORIES, INC.
K771811 10/19/1977 EMI CTR 100 EMI MEDICAL, INC.
K771930 10/27/1977 EMISONIC 4500 TM EMI MEDICAL, INC.
K771902 10/19/1977 EMI FOUR EMI THERAPY SYSTEMS, INC.
K771901 10/20/1977 CAPMIX ESPE DENTAL PRODUCTS
K771889 10/20/1977 UNIOLITE ESPE DENTAL PRODUCTS
K771853 10/13/1977 PERMAGUM ADHESIVE ESPE GMBH (US)
K771956 10/28/1977 HUMAN O BUFFER FLOW LABORATORIES, INC.
K771957 10/28/1977 RUBELLA HEMAGGLUTINATION REAGENT KIT FLOW LABORATORIES, INC.
K771768 10/07/1977 GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM G.D. SEARLE AND CO.
K771934 10/25/1977 LINEAR ARRAY B-MODE SCANNER G.D. SEARLE AND CO.
K771234 10/18/1977 TSH RIA REAGENT SET G.D. SEARLE AND CO.
K771828 10/25/1977 ALBUMIN GAMMA ENTERPRISES, INC.
K771830 10/25/1977 BLOOD UREA NITROGEN BUN GAMMA ENTERPRISES, INC.
K771831 10/25/1977 CALCIUM GAMMA ENTERPRISES, INC.
K771833 10/18/1977 CHOLESTEROL GAMMA ENTERPRISES, INC.
K771840 10/19/1977 TOTAL BILIRUBIN GAMMA ENTERPRISES, INC.
K771841 10/25/1977 TOTAL PROTEIN GAMMA ENTERPRISES, INC.
K771842 10/25/1977 URIC ACID GAMMA ENTERPRISES, INC.
K771844 10/25/1977 WASH SOLUTIONS GAMMA ENTERPRISES, INC.
K771812 10/18/1977 LIPPOPROTEIN ELECTROPHORESIS REAGENT SET GELMAN INSTRUMENT CO.
K761207 10/18/1977 HEMATRAK RBC MORPHOLOGY GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K771686 10/28/1977 UREAPLASMA DIFFERENTIAL BASAL AGAR MED. GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K771870 10/25/1977 MARTIN LEWIS AGAR (JEMBEC) GRANITE DIAGNOSTICS, INC.
K771871 10/25/1977 MARTIN LEWIS AGAR (PLATE) GRANITE DIAGNOSTICS, INC.
K771872 10/25/1977 MARTIN LEWIS TRANSGROW GRANITE DIAGNOSTICS, INC.
K771773 10/14/1977 CLINICARD CREATININE CHEMISTRY HARLECO
K771754 10/18/1977 GLUCOSE REAGENT FOR GLUC. ANALYZER HARLECO
K771224 10/11/1977 RADOVAN SUBCUTANEOUS TISSUE EXPANDER HEYER SCHULTE CORP.
K771731 10/25/1977 CHOLAR PRODU&T #17010 HI CHEM, INC.
K771714 10/05/1977 SLIDE STAINERS GLS 360 & 360-1 HONEYWELL, INC.
K771883 10/20/1977 REPLICA ACID-ETCH HOYT LABORATORIES
K771880 10/20/1977 REPLICA DENTAL COMPOSIT HOYT LABORATORIES
K771882 10/20/1977 REPLICA DENTAL COMPOSITE-RADIOPAQUE HOYT LABORATORIES
K771879 10/19/1977 GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771912 10/19/1977 LAS-R BETA LIPOPROTEIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771780 10/04/1977 LAS-R TM HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771703 10/04/1977 ENTERIC 20 INOLEX CORP./DIV OF BIOMEDICAL
K771337 10/18/1977 I.L. MODEL 643 FLAME PHOTOMETER INSTRUMENTATION LABORATORY CO.
K771507 10/25/1977 MULTISTAT III BICARBONATE TEST INSTRUMENTATION LABORATORY CO.
K771540 10/04/1977 MAGNATHERM 2000 INTL. MEDICAL ELECTRONICS LTD.
K771649 10/07/1977 HEMOGLOBIN A2 TESTING SYSTEM ISOLAB, INC.
K771806 10/04/1977 THOREK SCISSORS 7 1/4 & 10" J. SKLAR MFG. CO., INC.
K771647 10/19/1977 JEMBEC-CVSB PLATE J.P. KILBOURN, PH.D.
K771787 10/07/1977 AZIDE FREE BLOOD DILUTING REAGENT J.T. BAKER CHEMICAL CO.
K771789 10/07/1977 BLANKING SOLUTION HGB J.T. BAKER CHEMICAL CO.
K771788 10/07/1977 CYMET-AUTOMATED J.T. BAKER CHEMICAL CO.
K771790 10/07/1977 DETECTOTERGE "AZIDE FREE" J.T. BAKER CHEMICAL CO.
K771757 10/13/1977 EXAM GLOVES JAMAR HEALTH PRODUCTS
K771536 10/25/1977 AIR VENT FILTER NEEDLE, 0.45 JELCO LABORATORIES
K771551 10/04/1977 I.V. PREP & CARE KIT JELCO LABORATORIES
K771826 10/13/1977 INTRAVENOUS FILTER W/AUTO AIR VENT JELCO LABORATORIES
K771827 10/13/1977 INTRAVENOUS FILTER W/FLASH BULB JELCO LABORATORIES
K771381 10/13/1977 IV CATHETER HUB JELCO LABORATORIES
K771761 10/04/1977 SOLID OXYGEN SYSTEM JET RESEARCH CENTER, INC.
K771655 10/14/1977 CURITY PEAKOMETER KENDALL RESEARCH CENTER
K771958 10/25/1977 12MM SELF-SEALING TROCAR & CANNULA KLI
K771959 10/25/1977 8MM SELF-SEALING TROCAR & CANNULA KLI
K771964 10/25/1977 8MM TROCAR & CANNUAL W/STOPCOCK KLI
K771961 10/25/1977 DUAL INCISION TUBAL OCCLUS. BAND APPLI. KLI
K771963 10/25/1977 SINGLE INCISION TUBAL OCCLU. BAND APPL. KLI
K771960 10/25/1977 TUBAL OCCLUSION INSERTER/LAPAROSCOPE KLI
K771820 10/19/1977 ENZYMATIC CHOLESTEROL MACOMB CHEMICAL CO.
K771848 10/28/1977 PHOSPHORUS TEST KIT MALLINCKRODT CRITICAL CARE
K771779 10/05/1977 CATHETERIZATION SYS. URINARY DRAINAGE MEDICAL DEVICES, INC.
K771862 10/13/1977 TRANSFUSION BLOOD FILTER MEDICAL, INC.
K771824 10/19/1977 MEDPRO FLOTATION SYSTEM MEDPRO, INC.
K772013 10/28/1977 PERCUPASS TUNNELING TOOL MODEL 3452 MEDTRONIC VASCULAR
K771755 10/25/1977 9-WAY URINE TEST WITH ASCORBIC MILES LABORATORIES, INC.
K771767 10/25/1977 SERALUTE TSH (RIA) MILES LABORATORIES, INC.
K771713 10/18/1977 TEK-CHEK-2 MILES LABORATORIES, INC.
K771763 10/04/1977 HEMO-RO MILLIPORE CORP.
K771756 10/18/1977 FOLLICLE-STIMULATING HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K771783 10/14/1977 PTH RIA NICHOLS INSTITUTE DIAGNOSTICS
K771378 10/18/1977 NEO TSH-RIA KIT NUCLEAR MEDICAL SYSTEMS, INC.
K771888 10/21/1977 SYRINGE, DISPOSABLE ORTHOPEDIC EQUIPMENT CO., INC.
K770970 10/27/1977 HAIR TRANSPLANT PUNCH, MULTIPLH PADGETT INSTRUMENTS, INC.
K771860 10/18/1977 FOLHY CATHETER POLYSIL, INC.
K771409 10/27/1977 DISP. SURGICAL FACE MASK PRECEPT, INC.
K771918 10/20/1977 FIBEO OPTICS ILLUM. SYSTEM PROPPER MFG. CO., INC.
K771920 10/20/1977 FIBER OPTICS PROCTOSCOPE PROPPER MFG. CO., INC.
K771919 10/20/1977 FIBER OPTICS SIGMOIDOSCOPE PROPPER MFG. CO., INC.
K771421 10/25/1977 CATHETEO CLAMP QUINTON, INC.
K771484 10/25/1977 RINSE BLOCK ASSEM, D-W PERI. DIALYSIS QUINTON, INC.
K771428 10/18/1977 TENCKHOFF PERITONEAL TUBING ADAPT. QUINTON, INC.
K771704 10/18/1977 DERTRAN-COATED CHARCOAL TABLETS REFLEX INDUSTRIES, INC.
K771705 10/04/1977 RS-7800 MINIPUMP RENAL SYSTEMS, INC.
K771975 10/28/1977 ARTERIAL BLOOD SAMPLING TRAY RESPIRATORY CARE, INC.
K771851 10/27/1977 ARTHROSCOPE OPERATIVE KNIFE SET RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771850 10/18/1977 UROFLOW-CYSTOMETER SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771816 10/19/1977 ROCHE AXISCAN 5 ROCHE MEDICAL ELECTRONICS, INC.
K771695 10/18/1977 ALKALINE PHOSPHATASE TEST SCLAVO, INC.
K771876 10/28/1977 ARGYLE PEOCUSSOR SYSTEM SHERWOOD MEDICAL INDUSTRIES
K771712 10/13/1977 CATHETER DRESSING CHANCE SET SHIELD LABORATORIES, INC.
K771721 10/18/1977 BARBITAL BUFFER SIGMA CHEMICAL CO.
K771777 10/25/1977 PONCEAU S CONCENTRATE SIGMA CHEMICAL CO.
K771916 10/19/1977 PROCEDURE NO. 555 SIGMA CHEMICAL CO.
K771771 10/07/1977 QUAN. COLOR. DETER. OF SERUM ALBUMIN STANBIO LABORATORY
K771846 10/13/1977 SUOGIPEEL PACKAGING SYSTEM SURGICOT, INC.
K771657 10/13/1977 EMIT THYROXINE CONTROL SYVA CO.
K771822 10/19/1977 BG II ANALYZER TECHNICON INSTRUMENTS CORP.
K771592 10/18/1977 STAT/LYTE ANALYZER TECHNICON INSTRUMENTS CORP.
K771986 10/28/1977 CATHETER, MEDIASTINAL&PERICARDIAL THE MINNESOTA BACK BRACE CO.
K771569 10/25/1977 AUTOSTREAKER TOMTEC
K771539 10/07/1977 STEPPER TRIDAK
K771645 10/18/1977 ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE TRONOMED, INC.
K771766 10/07/1977 T3U UNION CARBIDE CORP.
K771178 10/18/1977 DISP. LOADING UNIT, AUTO, SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K771177 10/18/1977 SURGICAL STAPLING INSTRU., AUTO, SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K770835 10/05/1977 PATCH FABRIC USCI, DIV. C.R. BARD, INC.
K771808 10/19/1977 CLINAC 4/100 VARIAN ASSOC., INC.
K771809 10/19/1977 CLINAC 6/100 VARIAN ASSOC., INC.
K771073 10/25/1977 GAS CHROMA. ANALYSIS SYS., SERIES 37111 VARIAN ASSOC., INC.
K771256 10/07/1977 GAS CHROMATOGRAPH VARIAN ASSOC., INC.
K771637 10/25/1977 SPECTROPHOTOMETER ANALYSIS SYSTEM VARIAN ASSOC., INC.
K771762 10/04/1977 MODULAR HEARING DEVICE, MODEL S291 VICON INSTRUMENT CO.
K771729 10/21/1977 17-HYDROXYPROGESTERONE TEST SET WIEN LABORATORIES, INC.
K771863 10/13/1977 COLOR COTE WILLIAMS GOLD REFINING CO., INC.


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