FDA 510(k) Applications Received During October, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K760756 10/01/1976 BATTERY OPERATED FLOW RATE COMPUTER 3M HEALTH CARE, SARNS
K760889 10/26/1976 TEST FOR DETECTION OF ANTIRUBELLA ANTIB ABBOTT LABORATORIES
K760867 10/18/1976 STERILE STOCKINETTE ABCO DEALERS, INC.
K760908 10/26/1976 MINIATURE ASCENDING PAPER CHROMATO- ACKERMAN NUCLEAR, INC.
K760981 10/21/1976 ALGINATE IMPRESSION MATERIAL ADP INTL., INC.
K760986 10/21/1976 CARBIDE DENTAL BURS ADP INTL., INC.
K760979 10/21/1976 COMPOSITE MATERIAL ADP INTL., INC.
K760980 10/21/1976 DENTAL ALLOY ADP INTL., INC.
K760988 10/21/1976 DENTAL HANDPIECES ADP INTL., INC.
K760982 10/21/1976 DENTAL VARNISH ADP INTL., INC.
K760987 10/21/1976 DIAMOND STONES ADP INTL., INC.
K760983 10/21/1976 ENDODONTIC INSTRUMENTS ADP INTL., INC.
K760985 10/21/1976 HAND INSTRUMENTS ADP INTL., INC.
K760984 10/21/1976 ORTHODONTIC INSTRUMENTS ADP INTL., INC.
K760978 10/21/1976 ZINC CEMENT ADP INTL., INC.
K760816 10/12/1976 PNEUMOTACHOGRAPHY SYSTEM AFTERCAL, INC.
K760872 10/18/1976 PHOTOTHERAPY LIGHT AIR-SHIELDS, INC.
K760822 10/13/1976 MODEL TX-8 PANENDOSCOPE AMERICAN CYSTOCOPE MAKERS, INC.
K760911 10/27/1976 BREAST CARE KIT AMERICAN HOSPITAL SUPPLY CORP.
K760904 10/26/1976 CLEANING AND ISOLATION ROOM KIT AMERICAN HOSPITAL SUPPLY CORP.
K760912 10/27/1976 DRESSING CHANGE KIT AMERICAN HOSPITAL SUPPLY CORP.
K760806 10/12/1976 REFEREE AQUEOUS TRIGLYCERIDE STND ANALYTICAL PRODUCTS, INC.
K760882 10/21/1976 GE CT/T MODEL NO. B7800 A ARNOLD & PORTER FOR G.E. CO.
K760844 10/14/1976 CARDIAC OUTPUT COMPUTER (MODEL COC-100) B-D ELECTRODYNE
K760881 10/21/1976 FEBRILE ANTIGEN CONTROL SERA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760899 10/26/1976 STERILE DISPOSABLE COTTON PLUGGED SER. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K760900 10/26/1976 GAMMA SCINTILLATION COUNTER BECKMAN INSTRUMENTS, INC.
K760797 10/08/1976 SPIRAFLO DIALYZER, DISPOSABLE BENTLEY LABORATORIES, INC.
K760930 10/29/1976 BLOOD PRESSURE & PULSE CHECKER BIO MEGA DIAGNOSTIC, INC.
K760893 10/27/1976 AGGRECETIN BIO/DATA CORP.
K760764 10/04/1976 YEAST ASSIMILATION AGAR BIOQUEST
K760857 10/15/1976 TR-3 TRANSMITTER BURDICK CORP.
K760787 10/06/1976 LIBERATOR/STROLLER BURDITT & CALKINS-SIEMENS-ELEMA
K760786 10/06/1976 ENZYMATIC LIPASE MAX-PACK REAGENT CALBIOCHEM
K760926 10/29/1976 ELECTROCARDIOGRAPH (MODEL VS-4B) CAMBRIDGE INSTRUMENTS, INC.
K760773 10/04/1976 IMPEDANCE TESTER (MODEL 4370) CAMBRIDGE INSTRUMENTS, INC.
K760776 10/04/1976 IMPEDANCE TESTER (MODEL 4390) CAMBRIDGE INSTRUMENTS, INC.
K760777 10/04/1976 COLON-X CARLTON HYGIENICS, INC.
K760805 10/12/1976 ULTRASONIC DENTAL PROPHYLAXIS DEVICE CAVITRON CORP.
K760765 10/04/1976 WHOLE BLOOD PLATELET COUNTER -2510 CLAY ADAMS, DIV. BECTON DICKINSON & CO.
K760815 10/12/1976 FITTING/DIALYZER COBE LABORATORIES, INC.
K760961 10/29/1976 OCCLUSION CLIPS CODMAN & SHURTLEFF, INC.
K760770 10/04/1976 SOLA COMMIDO LOUPE CODMAN & SHURTLEFF, INC.
K760771 10/04/1976 SOLA SCHULTZE-CROCK OPTHALMOSCOPE CODMAN & SHURTLEFF, INC.
K760858 10/18/1976 RUTNER UNIVERSAL WEDGE CATHETER COOK, INC.
K760255 10/19/1976 TEST SYSTEM, THYROID STIM. HORMONE ASSAY CORNING MEDICAL & SCIENTIFIC
K760752 10/01/1976 CUTTER FLEX-SILICONE IMPRESSION MAT. CUTTER LABORATORIES, INC.
K760753 10/01/1976 CUTTER JEL-ALGINATE IMPRESSION MAT. CUTTER LABORATORIES, INC.
K760755 10/01/1976 CUTTER SIL-SILICONE IMPRESSION MAT CUTTER LABORATORIES, INC.
K760754 10/01/1976 CUTTER TRAY-ACRYLIC FOR IMP TRAYS CUTTER LABORATORIES, INC.
K760803 10/12/1976 PHYSIOLOGICAL MONITOR (MODEL 870) DATASCOPE CORP.
K760895 10/26/1976 AUTOMATIC SHUT-OFF VALVE DELTA MEDICAL INDUSTRIES
K760894 10/26/1976 VACUUM RELIEF VALVE DELTA MEDICAL INDUSTRIES
K760750 10/01/1976 STERILE TUBULAR UNBLEACHED STOCKINETTE DENNISON MANUFACTURING CO.
K760783 10/05/1976 BIOBOND-CROWN & BRIDGE CERAMIC BONDING DENTSPLY INTL.
K760802 10/12/1976 T-3 UPTAKE KIT DIAGNOSTIC PRODUCTS CORP.
K760801 10/12/1976 TSH RIA KIT DIAGNOSTIC PRODUCTS CORP.
K760897 10/26/1976 STERILE URETHRAL CATHETER KIT DIAMED DIVISION ILL. TOOL WORKS, INC.
K760931 10/29/1976 I.V. DRIP MONITOR ALARM DEVICE, MONIFLO DIEMOLDING CORP.
K760860 10/18/1976 SILASTIC ILEAL RESERVOIR CATHETER DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K760763 10/04/1976 COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I DYNATECH CRYOMEDICAL CO.
K760898 10/26/1976 GOLDFARB LIVER CLAMP EDWARD WECK, INC.
K760781 10/05/1976 TRIEX-1 HOLLOW FIBER DIALYZER EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K760768 10/04/1976 FLEXIDENT DENTURE FLEXODENT CORP.
K760766 10/04/1976 PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER FRASER SWEATMAN, INC.
K760808 10/12/1976 PHO. TRAX MODEL 4000 WHOLE BODY SCAN. G.D. SEARLE AND CO.
K760804 10/12/1976 T-PUMP, TEMPERATURE - THERAPY PUMP GAYMAR INDUSTRIES, INC.
K760790 10/07/1976 MICRO-ID GENERAL DIAGNOSTICS
K760905 10/26/1976 SUPERMAX AUTOMATIC X-RAY PROCESSOR GENERAL ELECTRIC CO.
K760874 10/18/1976 V.I. OCTOSON ULTRASONIC SYSTEM GENERAL ELECTRIC CO.
K760910 10/27/1976 DISPOSABLE K-PADS GORMAN RUPP INDUSTRIES
K760774 10/04/1976 TIME-SHARING MULTIPLEXER (MODEL 78308A) HEWLETT-PACKARD CO.
K760841 10/13/1976 HEXCELITE SHEET SPLINTS HEXCEL MEDICAL
K760785 10/05/1976 MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH HEYER SCHULTE CORP.
K760784 10/05/1976 MISHLER 2 CHAMB FLUSHING VALVE,STAND HEYER SCHULTE CORP.
K760778 10/04/1976 T-TUBE DRAIN, ROUND HEYER SCHULTE CORP.
K760767 10/04/1976 MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM HONEYWELL, INC.
K760878 10/21/1976 BONGORT ILEOSTOMY POUCH HOWMEDICA CORP.
K760842 10/14/1976 GEOMEDIC ANAMETRIC TOTAL KNEE HOWMEDICA CORP.
K760906 10/26/1976 MONOMER VAPOR CONTAINMENT SYSTEM HOWMEDICA CORP.
K760918 10/28/1976 HEPARIN CONTROL PLASMA HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760916 10/28/1976 LAS-R HUMAN ALPHA, ANTITRYPSIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760917 10/28/1976 LAS-R HUMAN HAPTOGLOBIN TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760818 10/12/1976 TRIS BICARBONATE DILUENT HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K760835 10/13/1976 ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) I M, INC.
K760833 10/13/1976 ANTI-BLASTOMYCES CONTROL SERUM (YEAST) I M, INC.
K760834 10/13/1976 ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) I M, INC.
K760832 10/13/1976 ANTI-HISTOPLASMA CONTROL SERUM (YEAST) I M, INC.
K760831 10/13/1976 ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) I M, INC.
K760830 10/13/1976 ASPERGILLUS MYCELIAL ANTIGEN I M, INC.
K760828 10/13/1976 BLASTOMYCES YEAST ANTIGEN I M, INC.
K760829 10/13/1976 COCCIDIOIDES MYCELIAL ANTIGEN I M, INC.
K760825 10/13/1976 FUNGAL IMMUNODIFFUSION KIT I M, INC.
K760826 10/13/1976 HISTOPLASMA MYCELIAL ANTIGEN I M, INC.
K760827 10/13/1976 HISTOPLASMA YEAST ANTIGEN I M, INC.
K760838 10/13/1976 LACTO-PHENOL COTTON BLUE MOUNTING FL. I M, INC.
K760836 10/13/1976 NEGATIVE CONTROL SERUM I M, INC.
K760837 10/13/1976 POTASSIUM HYDROXIDE W/GLYCEROL MTG FL. I M, INC.
K760839 10/13/1976 VASPAR, SEALANT FOR FERMENTATIONS I M, INC.
K760762 10/04/1976 INCENTIVE SPIROMETER I-SPIRON
K760891 10/26/1976 INSPIRON I.M.V. SET UP INSPIRON CORP.
K760856 10/15/1976 BLOOD CELL PROCESSOR MODEL 2 IBM 2991 INTL. BUSINESS MACHINES
K760800 10/08/1976 SPAC DIGOXIN KIT MALLINCKRODT CRITICAL CARE
K760870 10/18/1976 HEEL/ELBOW FLOTATION CUSHION MEDPRO, INC.
K760751 10/01/1976 CONTINUOUS WAVE DOPPLER MEDSONICS
K760795 10/08/1976 FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. MIDWEST
K760794 10/08/1976 FIBER OPTICS HIGH SPEED HANDPIECE MIDWEST
K760796 10/08/1976 ORALUMINATOR III - LIGHT SOURCE FOR F.O. MIDWEST
K760820 10/13/1976 NALGENE EMERGENCY EYE WASH NAGLE CO.
K760883 10/21/1976 DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY NUCLEAR MEDICAL LABORATORIES, INC.
K760819 10/12/1976 CONDUCTIVE ANESTHESIA BREATHING CIRCUIT OMNICON MEDICAL CORP.
K760869 10/18/1976 SPLIT CERVICAL COLLAR/HEAD HALTER ORTHOPEDIC EQUIPMENT CO., INC.
K760868 10/18/1976 VEST RESTRAINT ORTHOPEDIC EQUIPMENT CO., INC.
K760757 10/01/1976 MODEL 100 CARDIAC PACEMAKER PACESETTER SYSTEMS
K760846 10/15/1976 PAKOSTAT II PAKO CORP.
K760758 10/01/1976 STERILIZATION PACKAGING MATERIALS PAPER MANUFACTURERS CO.
K760817 10/12/1976 ORTHOPEDIC TUBULAR STOCKINETTE PARKE-DAVIS CO.
K760924 10/28/1976 TUCKS POLYPAD MATERNITY CARE PAD PARKE-DAVIS CO.
K760853 10/15/1976 STAYFREE DEODORANT MINI-PADS PERSONAL PRODUCTS CO.
K760909 10/26/1976 THERMOMETER JARS AND CAPS PLASTICS/PACKAGING
K760932 10/29/1976 BOUNDARY FABRIC III SURGICAL DRAPE PROCTER & GAMBLE MFG. CO.
K760923 10/28/1976 HUMIDIFIER-CASCADE II PURITAN BENNETT CORP.
K760887 10/22/1976 COMPRESSION ADJUSTRETTE QUALITONE
K760854 10/15/1976 THREE-CHANNEL STRESS TEST SYSTEM (M633) QUINTON, INC.
K760866 10/18/1976 CONCHA-COLUMN RESPIRATORY CARE, INC.
K760845 10/14/1976 "SOLO-SPHERE HEATER" RESPIRATORY THERAPY
K760929 10/29/1976 ACCUTORQ II RITTER CO.
K760919 10/28/1976 MODEL 2106 FETA SONDE FETAL MONITOR ROCHE MEDICAL ELECTRONICS, INC.
K760927 10/28/1976 STOMA SHIELD ADAPTER RUDOLFO T. SANCHEZ
K760798 10/08/1976 FLUOCAL GEL MINT SEPTODONT, INC.
K760799 10/08/1976 FLUOCAL GEL ORANGE SEPTODONT, INC.
K760759 10/04/1976 ANESTHESIA KIT SHERWOOD MEDICAL INDUSTRIES
K760876 10/04/1976 ARGYLE IV STARTER KIT (W/O DRUG) SHERWOOD MEDICAL INDUSTRIES
K760760 10/04/1976 CATHETER, INTRAVASCULAR (ARGYLE IV SK) SHERWOOD MEDICAL INDUSTRIES
K760761 10/04/1976 ESOPHAGEAL MOTILITY TUBE SHERWOOD MEDICAL INDUSTRIES
K760811 10/12/1976 GLOVE, SURGEON SHERWOOD MEDICAL INDUSTRIES
K760814 10/12/1976 HEPARINIZED PENROSE TUBING SHERWOOD MEDICAL INDUSTRIES
K760813 10/12/1976 HEPARINIZED SARATOGA SUMP DRAIN SHERWOOD MEDICAL INDUSTRIES
K760812 10/12/1976 HEPARINIZED WOUND SUCTION TUBING SHERWOOD MEDICAL INDUSTRIES
K760871 10/18/1976 LANCER MB/CPK ISOENZYME KIT SHERWOOD MEDICAL INDUSTRIES
K760877 10/04/1976 MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT SHERWOOD MEDICAL INDUSTRIES
K760810 10/02/1976 TUBE, GASTRO-ENTEROSTOMY SHERWOOD MEDICAL INDUSTRIES
K760922 10/28/1976 PERFUSION TUBING SET SHILEY, INC.
K760885 10/22/1976 KETOTROL-E SIGMA CHEMICAL CO.
K760862 10/18/1976 PROCEDURE NO. 710-EP FOR ALK.PHOS. SIGMA CHEMICAL CO.
K760863 10/18/1976 PRODUCT #K3002 KETOTROL-N(URINE CONTROL) SIGMA CHEMICAL CO.
K760821 10/13/1976 REAGENT SYSTEM SIGMA CHEMICAL CO.
K760884 10/22/1976 MICRO-COMPUTER ARRHYTHONIA SYSTEM SPACELABS, INC.
K760779 10/05/1976 BARNER SHOE COVERS & COVERBOOTS SURGIKOS, INC.
K760864 10/18/1976 BARRIER FABRIC 450 SPECIALTY GOWN SURGIKOS, INC.
K760903 10/26/1976 BARRIER FABRIC 450 SURGICAL GOWNS SURGIKOS, INC.
K760865 10/18/1976 BARRIER FASHION BONNET SURGIKOS, INC.
K760807 10/12/1976 BARRIER GENERAL SURGERY PACK SURGIKOS, INC.
K760890 10/26/1976 BARRIER IMPERVIOUS S-OCKINETTE SURGIKOS, INC.
K760896 10/26/1976 BARRIER ORTHOPAEDIC SPLIT SHEET SURGIKOS, INC.
K760855 10/15/1976 BARRIER SURGICAL HOOD SURGIKOS, INC.
K760902 10/26/1976 BARRIER UNDER BUTTOCKS DRAPE SURGIKOS, INC.
K760933 10/29/1976 BARRIER UNIVERSAL SHEET SURGIKOS, INC.
K760861 10/18/1976 SURGICAL CORP. SURGIKOS, INC.
K760772 10/04/1976 DISPOSABLE ABDOMINAL BINDER TECNOL NEW JERSEY WOUND CARE, INC.
K760782 10/05/1976 TECNOL PATIENT USE ICE PACK TECNOL NEW JERSEY WOUND CARE, INC.
K760775 10/04/1976 TERUMO DISPOSABLE SPINAL NEEDLE TERUMO AMERICA, INC.
K760879 10/21/1976 ROOM AIR PURIFIER (TEX-DYN) TEXAS DYNAMICS
K760769 10/04/1976 TEMPERATURE REGULATED FIVE CELL HOLDERS THE PERKIN-ELMER CORP.
K760920 10/28/1976 CAT-A-KIT THE UPJOHN CO.
K760928 10/29/1976 BLOOD BANK DRI-BATH THERMOLYNE CORP.
K760859 10/18/1976 TRACOR MODEL RA 208 COMPLIANCE AUDIOM TRACOR INSTRUMENTS, INC.
K760880 10/21/1976 ADDITIVE CAP (2B8905) TRAVENOL LABORATORIES, S.A.
K760914 10/27/1976 DOUBLE ELUTRA-PACK UNIT TRAVENOL LABORATORIES, S.A.
K760780 10/05/1976 DOUBLE-ENDED NEEDLE TRAVENOL LABORATORIES, S.A.
K760823 10/13/1976 TMO OXYGENATOR RESERVOIR PUMP SET TRAVENOL LABORATORIES, S.A.
K760824 10/13/1976 TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I TRAVENOL LABORATORIES, S.A.
K760843 10/14/1976 PALEY TRANSPARENT MANIFOLD USCI, DIV. C.R. BARD, INC.
K760793 10/07/1976 ADAPTER FOR ELLIK EVACUATOR V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760851 10/15/1976 CONVERSE ALTAR RETRACTOR V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760791 10/07/1976 COOLEY ANGLED SCISSOR - 1MM PROBE POINT V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760848 10/15/1976 FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760847 10/15/1976 FELDSTEIN BLEPHAROPLASTY CLIP SHARP P V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760849 10/15/1976 FELDSTEIN BLEPHAROSTOMY CLIP SQUARE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760850 10/15/1976 PARKES HUMP GAUGE STRAIGHT 7" (18 CM) V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760792 10/07/1976 SCISSOR - 1.5MM PROBE POINT, ANGLED V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760886 10/22/1976 RECTAL TUBE DEVICE VAN SICKLE PLASTICS CO.
K760888 10/26/1976 MODEL 6/60 CRT VIDEO-SONAR VEXILAR, INC.
K760921 10/28/1976 AIR PURIFIER VITAIRE CORP.


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