FDA 510(k) Applications Received During November, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781876 11/02/1978 ISOLETTE INCUBATOR AIR-SHIELDS, INC.
K781964 11/20/1978 COMPRESSION DEVICES, LIMB ALBA-WALDENSIAN, INC.
K781845 11/01/1978 CAMSCAN SYSTEM AMERICAN OPTICAL CORP.
K781979 11/27/1978 SURGAIRTOME TWO AMERICAN STERILIZER CO.
K781856 11/06/1978 PLATE, LD PRESUMPTO ANAEROBE SYSTEMS
K781847 11/02/1978 LATEX, IN-HOUSE COMPOUNDED ARBROOK MFG. CORP.
K781846 11/01/1978 ADAPTER, CATHETER SHEATH ARROW INTL., INC.
K781978 11/27/1978 PUNCTURE KIT, DISPOSALBE VEIN ARROW INTL., INC.
K781982 11/27/1978 INCLINOMETER, VERMONT ASSOCIATES IN RADIOLOGY, INC.
K781900 11/13/1978 ANALYZER, AUTOMED CENTRIFUGAL AUTOGENIC SYSTEMS
K782000 11/22/1978 MONITOR, NON-INVASIVE BLOOD PRESSURE AUTOMATED SCREENING DEVICES
K781918 11/13/1978 IRRIGATOR, BODY CAVITY BCI, INC.
K781853 11/06/1978 CHOLESTEROL STANDARDS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781854 11/06/1978 PAD, B-D I.V. CATH. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781946 11/21/1978 RIA KIT, FERRITIN SOLID PHASE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781939 11/20/1978 REAGENT KIT, TRIGLYCERIDES BECKMAN INSTRUMENTS, INC.
K781931 11/20/1978 TAPE, ELASTOPLAST ELASTIC TEAR BEIERSDORF, INC.
K781948 11/21/1978 COLUMN TEST, HEMOGLOBIN A BIO-RAD
K781850 11/02/1978 RIA, QUANTIMUNE E3 BIO-RAD
K781910 11/14/1978 MONITOR, SENSOMATIII OXYGEN BIOCHEM INTERNATIONAL, INC.
K781949 11/21/1978 ELECTROSURGERY MODEL 771 BIRTCHER CORP.
K781921 11/13/1978 BILIRUBIN, DINGLE VALVE DPD BOEHRINGER MANNHEIM CORP.
K781877 11/06/1978 UNDERPADS, HIGH ABSORBANT POLYMER BRIDGEWATER MFG. CORP.
K781867 11/03/1978 WRITER, GEMINI-3 C-V MONITORS CORP.
K781954 11/21/1978 CATHETER INTRODUCERS, ARTERISE C.R. BARD, INC.
K781996 11/29/1978 ACID REAGENT, URIC SINGLE VIAL CALBIOCHEM-BEHRING CORP.
K781909 11/14/1978 CALCITONIN 125 CAMBRIDGE NUCLEAR RADIOPHARMACEUTICAL
K781911 11/14/1978 ECG ANALYZER, HIGH SPEED CARDIO-DYNAMICS LABORATORIES, INC.
K781932 11/20/1978 BLOOD PRESSURE RECORDER CARDIODYNE, INC.
K781887 11/07/1978 9100 DAYSTAR AND 9110 ORBITER PACKAGE CASTLE CO.
K781985 11/24/1978 BURN PAD, DRY, STERILE CHESEBROUGH-POND'S U.S.A. CO.
K781920 11/13/1978 VALVE, VENT-AWAY TWO-WAY CHESEBROUGH-POND'S U.S.A. CO.
K781919 11/13/1978 PLAQUE DETECTION SYSTEM CLAIROL, INC.
K781938 11/20/1978 RIA KIT, GAMMADAB ESTRIOL CLINICAL ASSAYS, INC.
K781960 11/21/1978 SURGICAL EYE SHIELD CONCEPT, INC.
K781947 11/21/1978 STROLLER, THERAPY CONVAID PRODUCTS, INC.
K781959 11/21/1978 SURGICAL GOWNS, SHEETS CONVERTORS
K781886 11/07/1978 DIALYSATE DELIVERY SYSTEM CORDIS CORP.
K781968 11/24/1978 BLOOD GAS SYSTEM MODEL 168 CORNING MEDICAL & SCIENTIFIC
K781970 11/24/1978 CHOLESTEROL REAGENT SUBSTRATE SET CORNING MEDICAL & SCIENTIFIC
K781953 11/21/1978 RIA KIT, IMMO PHASE CORNING MEDICAL & SCIENTIFIC
K781969 11/24/1978 BLOOD, HEMATOLOGY REFERENCE CONTROL COULTER ELECTRONICS, INC.
K781907 11/14/1978 EAR STOPPLES FOR NOISE ATTENTION CROWN DELTA CORP.
K781937 11/20/1978 PROTHESIS, METACARPAL CUTTER LABORATORIES, INC.
K781864 11/06/1978 ADAPTER KIT DAIG CORP.
K781881 11/06/1978 HEARING AID, MODEL 781 DANAVOX, INC.
K781890 11/06/1978 CHAMBER, MC-1 DISPOSABLE PRESSURE DELTA MEDICAL INDUSTRIES
K781955 11/21/1978 GUN, CEMENT DEPUY, INC.
K781935 11/20/1978 NU-GLAZE DERINGER-NEY INC.
K781933 11/20/1978 DISPENSOR, XENON GAS DIAGNOSTIC ISOTAPES, INC.
K781870 11/03/1978 IMPLANT, H.P. CONDYLAR DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K781942 11/17/1978 MINIWASH DYNATECH LABORATORIES, INC.
K781916 11/14/1978 FLEXT-THERM E-Z-EM, INC.
K781941 11/20/1978 ANALYSIS SYSTEM, PREP SAMPLE E.I. DUPONT DE NEMOURS & CO., INC.
K781958 11/21/1978 ANALYTICAL TEST PACK, CARBAMAZEPINE E.I. DUPONT DE NEMOURS & CO., INC.
K781957 11/21/1978 ANALYTICAL TEST PACK, PRIMIDONE E.I. DUPONT DE NEMOURS & CO., INC.
K781934 11/20/1978 PROCESSOR, MODEL M8 EASTMAN KODAK COMPANY
K781898 11/13/1978 CLEARING SOLUTION #ECA01976 ELECTROPHORESIS CORP. OF AMERICA
K781936 11/20/1978 SCANNER-EMI 7020 AND 7020R EMI MEDICAL, INC.
K781966 11/24/1978 DIALYZER, MAGNIFLO 100 PARALLEL PLATE ERIKA, INC.
K781863 11/06/1978 DEVICE, FEMALE INCONTINENCE ESCHMANN BROS. & WALSH LTD.
K781988 11/27/1978 SUCTION APPARATUS, POWERED BY COMP. AIR FARLEY, W.T.
K781945 11/21/1978 GLUCOSE OXIDASE REAGENT FERMCO BIOCHEMICS, INC.
K781930 11/15/1978 PANT LINER, DISP. INCONTINENT FIBRE FORMATIONS, INC.
K781885 11/07/1978 SERUM, BLOOD UREA NITIOGEN FISHER SCIENTIFIC CO., LLC.
K781884 11/07/1978 SERUM, CREATININE DETERMINATIONS FISHER SCIENTIFIC CO., LLC.
K781874 11/03/1978 MYCOPLASMA ARGININI FITC (30-403-41) FLOW LABORATORIES, INC.
K781875 11/03/1978 STAIN KIT FOR CELL CULTURES (30-100-00) FLOW LABORATORIES, INC.
K781975 11/27/1978 MOBILE CARRIER GENERAL X-RAY, INC.
K781976 11/27/1978 MOBILE X-RAY UNIT GENERAL X-RAY, INC.
K781963 11/22/1978 ELECTRODES, OFFSET AND DX GRAPHIC CONTROLS CORP.
K781901 11/13/1978 KANGA PANTS H.A. & J.E. WOOD, INC.
K781940 11/20/1978 EKG ELECTRODES, DISPOSABLE HAYES PRODUCTS, INC.
K781926 11/08/1978 VENTILATOR, INFANT MODEL 100 HEALTHDYNE, INC.
K781971 11/27/1978 KNEE SYSTEM, QUADRAXIAL CONSTRAINED HEXCEL MEDICAL
K781891 11/08/1978 PIPETTES, PLASTIC DISPOSABLE HILLWOOD CORP.
K781943 11/17/1978 TENDON ROD MODEL OR41PO3-6 HOLTER-HAUSNER INTL.
K781855 11/06/1978 LVV OPTION HONEYWELL, INC.
K781908 11/14/1978 BREATHING CIRCUIT PRODUCTS, ANESTHESIA HOSPITAK, INC.
K781843 11/01/1978 RECORDER, HOLTER ELECTROCARDIOGRAM HOVIK CORP.
K781923 11/16/1978 NON-RETENTION ENEMA SYSTEM HUDSON KENDALE ASSOC., INC.
K781851 11/03/1978 HEMOGLOBIN, TESTING SYSTEM ISOLAB, INC.
K781962 11/21/1978 DIJI-DENT J&J TECHNOLOGIES, INC.
K781857 11/06/1978 TRAY, ARTERIAL BLOOD GAS SAMPLING JELCO LABORATORIES
K781952 11/21/1978 PAPER TAPE, HYPO ALLERGENIC JOHNSON & JOHNSON PROFESSIONALS, INC.
K781951 11/21/1978 ANTISERA, RHODAMINE CONJUGATED FRAGMENT KALLESTAD LABORATORIES, INC.
K781883 11/07/1978 DILUTER, LSA 290 PIPETTER KALLESTAD LABORATORIES, INC.
K781903 11/13/1978 RIA KIT, QUANTITOPE CORTISOL KALLESTAD LABORATORIES, INC.
K781904 11/13/1978 RIA KIT, QUANTITOPE IGE KALLESTAD LABORATORIES, INC.
K781905 11/13/1978 RIA KIT, QUANTITOPE T3 UPTAKE KALLESTAD LABORATORIES, INC.
K781866 11/03/1978 CANNULA CADDY KATENA PRODUCTS, INC.
K781892 11/08/1978 LOCATOR, FOREIGN BODY KEELER OPTICAL PRODUCTS LTD.
K781987 11/24/1978 URINARY DRAINAGE BAG KELSAR CORP.
K781944 11/21/1978 STOCKINETTE KIMBERLY-CLARK CORP.
K781913 11/14/1978 INSUFFALATOR LAPARAOSCOPIC KLI
K781965 11/24/1978 LASER COAGULATOR, MODEL 41AK LASERTEK OY
K781977 11/27/1978 APPLICATOR, LEE IMPRESSION LEE PHARMACEUTICALS
K781869 11/03/1978 DROPPER, CEPTI-SEAL KOH SOLUTION MARION LABORATORIES, INC.
K781868 11/03/1978 DROPPER, CEPTI-SEAL LAVTOPHENOL MARION LABORATORIES, INC.
K781906 11/13/1978 BLOOD PRESSURE DEVICE, 400 SERIES MED-TEK CORP.
K781981 11/27/1978 DECONTAMINATION ITEMS BAG MEDICARE INDUSTRIES, INC.
K781924 11/10/1978 POUCHES AND TUBING, MEDI-SEAL MEDICARE INDUSTRIES, INC.
K781925 11/10/1978 POUCHES, GAS STERILIZATION MEDICARE INDUSTRIES, INC.
K781980 11/27/1978 RESPIRATORY THERAPY GAS POUCH MEDICARE INDUSTRIES, INC.
K781986 11/24/1978 TRANSMITTER, MODEL 9406 AND 9401 MEDTRONIC VASCULAR
K781878 11/06/1978 LIGHT, INSIDE MIDWEST
K781873 11/03/1978 RECORDER, STRIP CHART WITH PRINTER MIDWEST ANALOG & DIGITAL, INC.
K781961 11/21/1978 CONTROL STRIP FOR VISUAL URINALYSIS MILES LABORATORIES, INC.
K781974 11/27/1978 IMPLANT DRIVERS AND TIPS MITER, INC.
K781888 11/07/1978 ASSAY SYSTEM, FERRITIN I KIT NEW ENGLAND NUCLEAR
K781862 11/06/1978 BLOOD GROUP SUBSTANCE A NORTH AMERICAN BIOLOGICALS, INC.
K781896 11/06/1978 BLOOD GROUP SUBSTANCE A,B NORTH AMERICAN BIOLOGICALS, INC.
K781895 11/06/1978 BLOOD GROUP SUBSTANCE B NORTH AMERICAN BIOLOGICALS, INC.
K781973 11/27/1978 CARDIOPHONE NORTH AMERICAN MOTRONIC
K781871 11/03/1978 DIFFUSION OPTION, OMNI-LAB OHIO MEDICAL PRODUCTS
K781860 11/06/1978 ASSAY, CHROMOGENIC ANTITHROMBIN III ORTHO DIAGNOSTICS, INC.
K781917 11/13/1978 MUCUS ASPIRATOR OVUTIME, INC.
K781879 11/06/1978 HEATER, OXIMETER SYSTEM OXIMETRIX, INC.
K781880 11/06/1978 ASSAY KIT, THROMBO-SCREEN PACIFIC HEMOSTASIS
K781897 11/13/1978 STAT KIT, MICROPROTEIN PIERCE CHEMICAL CO.
K781852 11/06/1978 GLOVE, SUPERFLEX MOLDED PINNACLE DISTRIBUTORS, INC.
K781967 11/24/1978 HEMODIALYSIS CONCENTRATE, SODIU RENAL SYSTEMS, INC.
K781844 11/01/1978 FERRITIN KIT RIA PRODUCTS, INC.
K781990 11/27/1978 CARDIAC INSULATION PAD SHILEY, INC.
K781991 11/24/1978 ANGIOSKIP SIEMENS CORP.
K781984 11/24/1978 COLLIMATOR, HEART CONTOUR SIEMENS CORP.
K781983 11/24/1978 EXPLORAMAT, COSMIC 2 SIEMENS CORP.
K781992 11/24/1978 KOORDINAT ANGIO SIEMENS CORP.
K781893 11/08/1978 CONTROL, PROTEIN ELECTROPHORESIS SIGMA CHEMICAL CO.
K781859 11/06/1978 REAGENT SYSTEM, NO 46-OV FOR CPK SIGMA CHEMICAL CO.
K781927 11/16/1978 HUMAN II LENS SPECTRA-SHIELD, INC.
K781865 11/06/1978 IRON BINDING CAPICITY MODEL 0370 STANBIO LABORATORY
K781861 11/06/1978 FILTER, EXTRACORPOREAL BLOOD HOLDER SURGIKOS, INC.
K781997 11/30/1978 AUTORANGE TRI W-G, INC.
K781956 11/21/1978 CRYOSURGICAL DEVICE 2000 VALLEYLAB, INC.
K781872 11/03/1978 CLINAC 2500 VARIAN ASSOC., INC.
K781922 11/13/1978 PULMONARY MONITOR VITALOGRAPH LTD.
K781899 11/13/1978 UREA NITROGEN TEST WAKO INTL., INC.
K781889 11/07/1978 COLLINS PEDALMATE 2 WARREN E. COLLINS, INC.
K781915 11/14/1978 DATA MODULE WATERS ASSOC., INC.
K781989 11/27/1978 OMNIPREP WEAVER & CO.
K781994 11/29/1978 AUTOKERATOMETER, INSTRUMENT ZEISS HUMPHREY SYSTEM


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