FDA 510(k) Applications Received During September, 1977

FDA 510(k) Number Submission Date Device Name Applicant Contact
K771764 09/19/1977 CORONARY PRESSURE PERFUSION PUMP 3M HEALTH CARE, SARNS
K771819 09/26/1977 CABG RINGS A&A ENT.
K771858 09/29/1977 EXPAND. RETENTION ENDOSSEOUS IMPLANT A.L. MILLER, INC.
K771669 09/01/1977 DIAG. KIT FOR TOTAL ANTITHROMBIN III ABBOTT LABORATORIES
K771671 09/01/1977 AUDITORY TRAINER ACCUTONE, INC.
K771668 09/01/1977 DISP. FLUID ISOLATOR & PRESS. RELIEF AILTECH
K771699 09/06/1977 CARA-STAIN MODEL 3000 AMERICAN SAFETY EQUIPMENT CORP.
K771772 09/19/1977 DINAMAP MODEL 825A APPLIED MEDICAL RESEARCH
K771782 09/23/1977 DINIMAP MODEL 827A APPLIED MEDICAL RESEARCH
K771678 09/02/1977 THROMBO-SCREEN PLATELET ADHESION BAY AREA HEMA. ONCO. CLINIC. & RES. L
K771696 09/06/1977 EMODIALYSIS DEL. SYS. MODEL 7110 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771784 09/23/1977 IOPSY TRAY FOR SOFT TISSUE BIOPSY BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K771796 09/23/1977 RUBA-NOST TEST KITS BEHRING DIAGNOSTICS, INC.
K771758 09/19/1977 ELASTOMULL GAUZE BANDAGE BEIERSDORF, INC.
K771733 09/15/1977 8" EMESIS BASIN BEMIS HEALTH CARE
K771738 09/15/1977 MALE URINAL BEMIS HEALTH CARE
K771737 09/15/1977 SUCTION CANISTER BEMIS HEALTH CARE
K771689 09/06/1977 DIAL X COLLIMATOR MODEL A&B BENNETT X-RAY CORP.
K771711 09/12/1977 BIOTOME BERKELEY BIO-ENGINEERING
K771722 09/13/1977 SENSOMAT BIOCHEM INTERNATIONAL, INC.
K771825 09/27/1977 CARBA LINGUARDUC C.R. BARD, INC.
K771775 09/19/1977 COLORPLAST TRANSVERSE SYSTEM C.R. BARD, INC.
K771776 09/19/1977 ECG CLUSTER ELECTRODE C.R. BARD, INC.
K771750 09/15/1977 RF CHOKE CABLE C.R. BARD, INC.
K771792 09/22/1977 ENEMA SET CHASE MFG. CO.
K771791 09/22/1977 NEEDLE COUNTING CHASE MFG. CO.
K771813 09/27/1977 CENTRIFICHEM SYS 400 ANALYZER CLINICAL DIAGNOSTICS, INC.
K771692 09/06/1977 TUBING SETS COBE LABORATORIES, INC.
K771718 09/12/1977 CARDIOTHERM-500X COLUMBUS INSTRUMENTS INTL. CORP.
K771785 09/23/1977 IRRIGATING NEEDLE, ILLUMINATED CONCEPT, INC.
K771732 09/15/1977 THORNTON ANTERIOR CHAMBER IRRIGATOR CONCEPT, INC.
K771673 09/02/1977 CATHETEO CARE TRAY #0242 CONCORD LABORATORIES, INC.
K771855 09/28/1977 OMNICOR PROGRAMMER MODEL 222A CORDIS CORP.
K771753 09/16/1977 HEMATOLOGY REFERENCE CONTROL COULTER ELECTRONICS, INC.
K771740 09/15/1977 CARDIOZYME CK-CONTROL LEVEL 1 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K771746 09/15/1977 FORCEPS DEPUY, INC.
K771744 09/15/1977 OSTEOTOMES FOR CUTTING BONH DEPUY, INC.
K771747 09/15/1977 PERIOSTEAL ELEVATOR DEPUY, INC.
K771745 09/15/1977 RASPS FOR SCRAPING BONE DEPUY, INC.
K771743 09/15/1977 SURG. SCISSORS FOR CUTTING TISSUE DEPUY, INC.
K771708 09/12/1977 WORRELL PATELLA DEPUY, INC.
K771710 09/12/1977 WORRELL PATELLA TEMPLATE DEPUY, INC.
K771709 09/12/1977 WORRELL TRIAL PATELLA DEPUY, INC.
K771815 09/27/1977 SIGMOSCOPE DYNATECH CRYOMEDICAL CO.
K771799 09/23/1977 ACA ALCOHOL CALIBRATORS E.I. DUPONT DE NEMOURS & CO., INC.
K771804 09/23/1977 ACA AMMONIA CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771798 09/23/1977 ACA BILIRUBIN CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771801 09/23/1977 ACA CARBON DIOXIDE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771800 09/23/1977 ACA GLUTAMYL TRANSFERASE E.I. DUPONT DE NEMOURS & CO., INC.
K771802 09/23/1977 ACA IRON CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771803 09/23/1977 ACA PHOSPHORUS CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771805 09/23/1977 ACA SALICYLATE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771797 09/23/1977 ACA TRIGLYCERIDE CALIBRATOR E.I. DUPONT DE NEMOURS & CO., INC.
K771857 09/29/1977 AUTOMIXER, KODAK EASTMAN KODAK COMPANY
K771682 09/06/1977 MIN-R CASSETTE EASTMAN KODAK COMPANY
K771681 09/06/1977 ORTHO H FILM EASTMAN KODAK COMPANY
K771691 09/06/1977 ANGLED FORCEP APPLIER EDWARD WECK, INC.
K771751 09/16/1977 DISP. ELECTROSURGERY PENCIL EDWARD WECK, INC.
K771752 09/16/1977 FINGER TIP CONTROL PENCIL EDWARD WECK, INC.
K771859 09/29/1977 NEEDLE HOLDER, MICROVASCULAR EDWARD WECK, INC.
K771811 09/27/1977 EMI CTR 100 EMI MEDICAL, INC.
K771817 09/26/1977 EMI THERAPY SIMULATOR EMI THERAPY SYSTEMS, INC.
K771852 09/29/1977 NIMETIC POLISHING PASTE ESPE GMBH (US)
K771853 09/29/1977 PERMAGUM ADHESIVE ESPE GMBH (US)
K771679 09/06/1977 MICROFLATOR FISONS CORP.
K771768 09/19/1977 GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM G.D. SEARLE AND CO.
K771774 09/19/1977 NEW BASE FOR ORTHODONTIC APPLIANCES GAC INTL., INC. MARK MANNI
K771828 09/29/1977 ALBUMIN GAMMA ENTERPRISES, INC.
K771829 09/21/1977 ALKALINE PHOSPHATASE GAMMA ENTERPRISES, INC.
K771830 09/21/1977 BLOOD UREA NITROGEN BUN GAMMA ENTERPRISES, INC.
K771831 09/21/1977 CALCIUM GAMMA ENTERPRISES, INC.
K771832 09/21/1977 CHLORIDE GAMMA ENTERPRISES, INC.
K771833 09/21/1977 CHOLESTEROL GAMMA ENTERPRISES, INC.
K771834 09/21/1977 CREATININE GAMMA ENTERPRISES, INC.
K771835 09/21/1977 INORGANIC PHOSPHORUS GAMMA ENTERPRISES, INC.
K771836 09/21/1977 LACTATE DEHYDROGENASE GAMMA ENTERPRISES, INC.
K771837 09/21/1977 POTASSIUM GAMMA ENTERPRISES, INC.
K771838 09/21/1977 SERUM IRON GAMMA ENTERPRISES, INC.
K771839 09/21/1977 SODIUM GAMMA ENTERPRISES, INC.
K771840 09/21/1977 TOTAL BILIRUBIN GAMMA ENTERPRISES, INC.
K771841 09/21/1977 TOTAL PROTEIN GAMMA ENTERPRISES, INC.
K771842 09/21/1977 URIC ACID GAMMA ENTERPRISES, INC.
K771844 09/21/1977 WASH SOLUTIONS GAMMA ENTERPRISES, INC.
K771843 09/21/1977 WETTING AGENTS GAMMA ENTERPRISES, INC.
K771812 09/27/1977 LIPPOPROTEIN ELECTROPHORESIS REAGENT SET GELMAN INSTRUMENT CO.
K771748 09/15/1977 INTRA ORAL X-RAY CONES GENERAL ELECTRIC CO.
K771686 09/06/1977 UREAPLASMA DIFFERENTIAL BASAL AGAR MED. GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K771742 09/15/1977 EVOKED RESPONSE SYS., MODEL 10 GRASS INSTRUMENT CO.
K771773 09/19/1977 CLINICARD CREATININE CHEMISTRY HARLECO
K771754 09/16/1977 GLUCOSE REAGENT FOR GLUC. ANALYZER HARLECO
K771731 09/14/1977 CHOLAR PRODU&T #17010 HI CHEM, INC.
K771683 09/06/1977 AMPLIFIER MODEL N3B-EEG HONEYWELL, INC.
K771684 09/06/1977 AMPLIFIER MODEL N5A-ECG HONEYWELL, INC.
K771685 09/06/1977 AMPLIFIER MODEL N5A-HIS HONEYWELL, INC.
K771714 09/12/1977 SLIDE STAINERS GLS 360 & 360-1 HONEYWELL, INC.
K771795 09/23/1977 LAS-R CERULOPLASMIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771780 09/23/1977 LAS-R TM HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771700 09/07/1977 TMA BICARBONATE/GLYCEROL DILUENT HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K771703 09/09/1977 ENTERIC 20 INOLEX CORP./DIV OF BIOMEDICAL
K771806 09/23/1977 THOREK SCISSORS 7 1/4 & 10" J. SKLAR MFG. CO., INC.
K771787 09/20/1977 AZIDE FREE BLOOD DILUTING REAGENT J.T. BAKER CHEMICAL CO.
K771789 09/20/1977 BLANKING SOLUTION HGB J.T. BAKER CHEMICAL CO.
K771788 09/20/1977 CYMET-AUTOMATED J.T. BAKER CHEMICAL CO.
K771716 09/12/1977 CYMET-PLUS J.T. BAKER CHEMICAL CO.
K771790 09/20/1977 DETECTOTERGE "AZIDE FREE" J.T. BAKER CHEMICAL CO.
K771847 09/28/1977 TEMP-TESTER JABLECKI, CHARLES, DR.
K771757 09/16/1977 EXAM GLOVES JAMAR HEALTH PRODUCTS
K771826 09/19/1977 INTRAVENOUS FILTER W/AUTO AIR VENT JELCO LABORATORIES
K771827 09/19/1977 INTRAVENOUS FILTER W/FLASH BULB JELCO LABORATORIES
K771761 09/20/1977 SOLID OXYGEN SYSTEM JET RESEARCH CENTER, INC.
K771719 09/12/1977 KARAYA ELECTRODES LECTEC CORP.
K771820 09/23/1977 ENZYMATIC CHOLESTEROL MACOMB CHEMICAL CO.
K771849 09/28/1977 CPK COLOR TEST KIT MALLINCKRODT CRITICAL CARE
K771848 09/28/1977 PHOSPHORUS TEST KIT MALLINCKRODT CRITICAL CARE
K771765 09/19/1977 MYO-CHECK MED GENERAL
K771701 09/08/1977 VESSEL-CLUDE MED GENERAL
K771702 09/08/1977 VESSEL-STABILIZER MED GENERAL
K771779 09/21/1977 CATHETERIZATION SYS. URINARY DRAINAGE MEDICAL DEVICES, INC.
K771676 09/02/1977 FOOT DROP BOOT MEDICAL RESTRAINTS, INC.
K771715 09/12/1977 PELVIC WHEELCHAIR RESTRAINT MEDICAL RESTRAINTS, INC.
K771824 09/27/1977 MEDPRO FLOTATION SYSTEM MEDPRO, INC.
K771786 09/21/1977 CARDIAC PULSE GENERATORS 5982/5983 MEDTRONIC VASCULAR
K771770 09/19/1977 XYREL-RA MODELS 5994/5995 MEDTRONIC VASCULAR
K771755 09/16/1977 9-WAY URINE TEST WITH ASCORBIC MILES LABORATORIES, INC.
K771672 09/01/1977 MICROCULT-ID MILES LABORATORIES, INC.
K771767 09/19/1977 SERALUTE TSH (RIA) MILES LABORATORIES, INC.
K771713 09/12/1977 TEK-CHEK-2 MILES LABORATORIES, INC.
K771763 09/19/1977 HEMO-RO MILLIPORE CORP.
K771749 09/15/1977 AMALGAM DISPENSER NEW DIMENSIONS IN MEDICINE, INC.
K771756 09/16/1977 FOLLICLE-STIMULATING HORMONE NICHOLS INSTITUTE DIAGNOSTICS
K771783 09/23/1977 PTH RIA NICHOLS INSTITUTE DIAGNOSTICS
K771706 09/09/1977 SAIF-BOW NORTHWEST ORTHODONTICS, INC.
K771854 09/28/1977 SPINSEP-T3 NUCLEAR DIAGNOSTICS, INC.
K771814 09/27/1977 REAGENT CONFIDENCE SERA ORTHO DIAGNOSTICS, INC.
K771760 09/19/1977 EXTEMP PHARMACO, INC.
K771759 09/19/1977 EXTEMP-V PHARMACO, INC.
K771810 09/27/1977 PRESSURE TUBING PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K771723 09/13/1977 HILL TUBE PHYSIO-CONTROL CORP.
K771739 09/15/1977 PENTAX LH-150F LIGHT SOURCE PILLING CO.
K771860 09/30/1977 FOLHY CATHETER POLYSIL, INC.
K771697 09/06/1977 CARDIO-EXERCISE TREADMILL 550 QUINTON, INC.
K771704 09/06/1977 DERTRAN-COATED CHARCOAL TABLETS REFLEX INDUSTRIES, INC.
K771705 09/09/1977 RS-7800 MINIPUMP RENAL SYSTEMS, INC.
K771851 09/29/1977 ARTHROSCOPE OPERATIVE KNIFE SET RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771850 09/29/1977 UROFLOW-CYSTOMETER SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K771816 09/27/1977 ROCHE AXISCAN 5 ROCHE MEDICAL ELECTRONICS, INC.
K771695 09/06/1977 ALKALINE PHOSPHATASE TEST SCLAVO, INC.
K771712 09/12/1977 CATHETER DRESSING CHANCE SET SHIELD LABORATORIES, INC.
K771720 09/13/1977 AMIDO BLACK CONCENTRATE SIGMA CHEMICAL CO.
K771721 09/13/1977 BARBITAL BUFFER SIGMA CHEMICAL CO.
K771777 09/20/1977 PONCEAU S CONCENTRATE SIGMA CHEMICAL CO.
K771856 09/29/1977 DIR. QUANT. COLOR. DETERM. SERUM CREAT. STANBIO LABORATORY
K771771 09/19/1977 QUAN. COLOR. DETER. OF SERUM ALBUMIN STANBIO LABORATORY
K771680 09/06/1977 ARMOR-KOT SURGICAL INSTRUMENTS STORZ INSTRUMENT CO.
K771688 09/06/1977 ECHO-OCULOMETER STORZ INSTRUMENT CO.
K771846 09/28/1977 SUOGIPEEL PACKAGING SYSTEM SURGICOT, INC.
K771728 09/14/1977 AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 TECHNICON INSTRUMENTS CORP.
K771822 09/22/1977 BG II ANALYZER TECHNICON INSTRUMENTS CORP.
K771821 09/23/1977 STAC SYSTEM TECHNICON INSTRUMENTS CORP.
K771670 09/01/1977 IMPLANTED PACEMAKER PLUSE GENERATOR TELECTRONICS, INC.
K771693 09/06/1977 CLIRANS BLOOD LINES SET TERUMO AMERICA, INC.
K771694 09/06/1977 CLIRANS TH 15 HOLLOW FIBER DIALYZER TERUMO AMERICA, INC.
K771707 09/09/1977 ADIDYNE 3000 TIMETER INSTRUMENT CORP.
K771766 09/19/1977 T3U UNION CARBIDE CORP.
K771823 09/23/1977 CATHETER, CARDIOVASCULAR USCI, DIV. C.R. BARD, INC.
K771808 09/27/1977 CLINAC 4/100 VARIAN ASSOC., INC.
K771809 09/27/1977 CLINAC 6/100 VARIAN ASSOC., INC.
K771807 09/26/1977 SPECTROPHOTOMETER ANALYSIS SYS. VARIAN ASSOC., INC.
K771762 09/19/1977 MODULAR HEARING DEVICE, MODEL S291 VICON INSTRUMENT CO.
K771769 09/19/1977 TINNITUS MASKERS, MODELS S564&S574 VICON INSTRUMENT CO.
K771729 09/14/1977 17-HYDROXYPROGESTERONE TEST SET WIEN LABORATORIES, INC.
K771793 09/22/1977 DHEA TEST SET WIEN LABORATORIES, INC.
K771725 09/13/1977 BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. XOMED, INC.
K771727 09/13/1977 BIOSPONGE RECONSTRUCTION DISCS XOMED, INC.
K771726 09/13/1977 BIOSPONGE STAPES PISTON XOMED, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact