FDA 510(k) Decisions During December, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781000 12/04/1978 PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS ABBOTT LABORATORIES
K781727 12/04/1978 CHANGE IN STERILIZATION PROCEDURE ABSORBENT COTTON CO., INC.
K781832 12/07/1978 SCALE, ACME DIGITAL BEDSIDE ACME MEDICAL SCALE CO.
K782005 12/20/1978 RADIATION ONCOLOGY SYSTEM ADAC LABORATORIES
K781876 12/07/1978 ISOLETTE INCUBATOR AIR-SHIELDS, INC.
K781964 12/12/1978 COMPRESSION DEVICES, LIMB ALBA-WALDENSIAN, INC.
K781979 12/20/1978 SURGAIRTOME TWO AMERICAN STERILIZER CO.
K781456 12/04/1978 ENDOCARDIAL BIPOLAR LEAD AMERICAN TECHNOLOGY, INC.
K781326 12/04/1978 UNIPOPLAR ENDOCARDIAL LEADS AMERICAN TECHNOLOGY, INC.
K782064 12/28/1978 TABLE, EXAMINING-TWO EIGHTY AMSCO CO.
K781567 12/20/1978 API ZYM ANALYTICAL PRODUCTS, INC.
K781728 12/20/1978 EXTUBE ANALYTICHEM INTERNATIONAL, INC.
K782146 12/27/1978 PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT ARCO MEDICAL PRODUCTS CO.
K781846 12/12/1978 ADAPTER, CATHETER SHEATH ARROW INTL., INC.
K781978 12/12/1978 PUNCTURE KIT, DISPOSALBE VEIN ARROW INTL., INC.
K782001 12/07/1978 ROSEALAE ASMB
K781982 12/04/1978 INCLINOMETER, VERMONT ASSOCIATES IN RADIOLOGY, INC.
K781900 12/20/1978 ANALYZER, AUTOMED CENTRIFUGAL AUTOGENIC SYSTEMS
K782000 12/05/1978 MONITOR, NON-INVASIVE BLOOD PRESSURE AUTOMATED SCREENING DEVICES
K781816 12/07/1978 INOCULATOR, AIM-4 MICROPROCESSOR AXFORD MANUFACTURING LTD.
K781749 12/04/1978 TUBING, AXIOM SILICONE PENROSE AXIOM MEDICAL, INC.
K781731 12/05/1978 INCENT-O-NEB B & F MEDICAL PRODUCTS, INC.
K781800 12/07/1978 GRIP, HOSPITAL UTILITY BAKA MANUFACTURING CO., INC.
K781853 12/04/1978 CHOLESTEROL STANDARDS BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781854 12/04/1978 PAD, B-D I.V. CATH. BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781931 12/07/1978 TAPE, ELASTOPLAST ELASTIC TEAR BEIERSDORF, INC.
K780897 12/06/1978 GENERATOR, PULSE, SORIN MODEL DL-1 BENTLEY LABORATORIES, INC.
K781757 12/04/1978 SERACON-SRI BHP DIAGNOSTIX, INC.
K781758 12/04/1978 SERACON-SRII BHP DIAGNOSTIX, INC.
K781948 12/20/1978 COLUMN TEST, HEMOGLOBIN A BIO-RAD
K781910 12/26/1978 MONITOR, SENSOMATIII OXYGEN BIOCHEM INTERNATIONAL, INC.
K781691 12/20/1978 CHEMSTRIP CONTROL BOEHRINGER MANNHEIM CORP.
K781632 12/20/1978 UROTRON BOEHRINGER MANNHEIM CORP.
K781760 12/20/1978 HUMIDIFIERS, MODEL:LS-420 AND LS-460 BOURNS MEDICAL SYSTEMS, INC.
K781877 12/15/1978 UNDERPADS, HIGH ABSORBANT POLYMER BRIDGEWATER MFG. CORP.
K782059 12/21/1978 TRANSMITTER, TR-1 ECG BURDICK CORP.
K782082 12/20/1978 CATHETER, DIGITAL POSITRAL II C.R. BARD, INC.
K782071 12/15/1978 CATHETER, USCI GRUNTZIG/BALLOON C.R. BARD, INC.
K781767 12/07/1978 INSTRUMENT CURNETT MINI-CONER BIOPSY C.R. BARD, INC.
K781766 12/07/1978 UTERINE SOUND, BURNETT DISPOSABLE C.R. BARD, INC.
K782022 12/22/1978 MICROLITH A MODEL 703 CARDIAC PACEMAKERS, INC.
K782023 12/22/1978 MICROLITH A MODEL 803 CARDIAC PACEMAKERS, INC.
K781887 12/12/1978 9100 DAYSTAR AND 9110 ORBITER PACKAGE CASTLE CO.
K781746 12/05/1978 MINICO CATALYST RESEARCH CORP.
K782065 12/28/1978 LASER, PHOTOCOAGULATION CAVITRON CORP.
K781985 12/07/1978 BURN PAD, DRY, STERILE CHESEBROUGH-POND'S U.S.A. CO.
K781920 12/04/1978 VALVE, VENT-AWAY TWO-WAY CHESEBROUGH-POND'S U.S.A. CO.
K781919 12/04/1978 PLAQUE DETECTION SYSTEM CLAIROL, INC.
K781764 12/04/1978 PAD, COOLING #27-999 COBE LABORATORIES, INC.
K782090 12/20/1978 CLAMP, DISPOSABLE CONCORD LABORATORIES, INC.
K781947 12/04/1978 STROLLER, THERAPY CONVAID PRODUCTS, INC.
K781377 12/04/1978 OVALITH 10BP CORATOMIC, INC.
K781785 12/07/1978 I.V. SET WITH IN-LINE FILTER CUTLER LABORATORIES, INC.
K781864 12/19/1978 ADAPTER KIT DAIG CORP.
K782004 12/15/1978 LEAD, TIMED PACING, IMPLANTABLE DAIG CORP.
K782026 12/12/1978 FLAT SILICONE DRAIN DAVOL, INC.
K782027 12/20/1978 HYSTERECTOMY "T" DRAIN DAVOL, INC.
K782028 12/20/1978 ROUND SILICONE DRAIN DAVOL, INC.
K781890 12/04/1978 CHAMBER, MC-1 DISPOSABLE PRESSURE DELTA MEDICAL INDUSTRIES
K781777 12/20/1978 ABRASIVE WHEELS DENTSPLY INTL.
K781955 12/04/1978 GUN, CEMENT DEPUY, INC.
K781935 12/20/1978 NU-GLAZE DERINGER-NEY INC.
K781933 12/04/1978 DISPENSOR, XENON GAS DIAGNOSTIC ISOTAPES, INC.
K781942 12/04/1978 MINIWASH DYNATECH LABORATORIES, INC.
K781934 12/04/1978 PROCESSOR, MODEL M8 EASTMAN KODAK COMPANY
K781649 12/07/1978 ULTRASONIC TRANSDUCERS ECHO LABORATORIES, INC.
K781715 12/04/1978 RULER, WECK SCOTT EDWARD WECK, INC.
K781898 12/20/1978 CLEARING SOLUTION #ECA01976 ELECTROPHORESIS CORP. OF AMERICA
K781455 12/07/1978 SIEMENS ULTRATHERM 708 ELMED, INC.
K781936 12/04/1978 SCANNER-EMI 7020 AND 7020R EMI MEDICAL, INC.
K781002 12/04/1978 TEMPORARY CARDIAC PACING WIRE ETHICON, INC.
K781633 12/07/1978 ULTRAFILTRATION SCALE EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K781988 12/12/1978 SUCTION APPARATUS, POWERED BY COMP. AIR FARLEY, W.T.
K781885 12/20/1978 SERUM, BLOOD UREA NITIOGEN FISHER SCIENTIFIC CO., LLC.
K781884 12/20/1978 SERUM, CREATININE DETERMINATIONS FISHER SCIENTIFIC CO., LLC.
K781874 12/20/1978 MYCOPLASMA ARGININI FITC (30-403-41) FLOW LABORATORIES, INC.
K781875 12/20/1978 STAIN KIT FOR CELL CULTURES (30-100-00) FLOW LABORATORIES, INC.
K781523 12/01/1978 PFT GASES GARDNER CRYOGENICS
K781630 12/04/1978 GE-700 INTRA ORAL X-RAY SYSTEM GENERAL ELECTRIC CO.
K782029 12/22/1978 MAXI CAMERA 400T GENERAL ELECTRIC CO.
K781975 12/04/1978 MOBILE CARRIER GENERAL X-RAY, INC.
K781976 12/04/1978 MOBILE X-RAY UNIT GENERAL X-RAY, INC.
K781675 12/04/1978 X-RAY COLLIMATOR GENERAL X-RAY, INC.
K781783 12/04/1978 BLOOD SUGAR GILFORD DIAGNOSTICS
K781269 12/04/1978 ELISA SYSTME GILFORD INSTRUMENT LABORATORIES, INC.
K780894 12/14/1978 AIRFLOMETER GLAXO AUSTRALIA PLY. LTD.
K781963 12/19/1978 ELECTRODES, OFFSET AND DX GRAPHIC CONTROLS CORP.
K782053 12/15/1978 HEARING AID, POST-AURICULAR HC ELECTRONICS
K782076 12/29/1978 HT-110 MICROMINI HEALTH TECH
K781926 12/21/1978 VENTILATOR, INFANT MODEL 100 HEALTHDYNE, INC.
K781592 12/04/1978 SURGICAL ASPIRATOR TIPS HENRY SCHEIN, INC.
K781771 12/20/1978 DETECTOR, MODEL 79875A, VARIABLE HEWLETT-PACKARD CO.
K781943 12/04/1978 TENDON ROD MODEL OR41PO3-6 HOLTER-HAUSNER INTL.
K780938 12/15/1978 SUPER-SORBER HOME HEALTHCARE PRODUCTS, INC.
K781693 12/07/1978 COLLAGENREAGENT "HORM" HORMON-CHEMIE MUNCHEM GMCH
K780527 12/20/1978 CORTRAL I HOSPAL MEDICAL CORP.
K781464 12/20/1978 HEMODIALYZER, MODEL RP610, RP AN 69 HOSPAL MEDICAL CORP.
K781762 12/20/1978 COMPRESSION HIP SCREW SYSTEM HOWMEDICA CORP.
K781831 12/15/1978 SPIROMETER, INCENTIVE CATALOG # 1750 HUDSON OXYGEN THERAPY SALES CO.
K781546 12/04/1978 DIRECT ESTRIOL RIA KIT IMMUNALYSIS CORPORATION
K781741 12/01/1978 MASK, BI FLO NASAL OXYGEN INHAL-O-TECH MEDICAL PLASTIC
K781575 12/04/1978 DISPOSABLE LYMPHANGIOGRAM SET INSTRANETICS, INC.
K782033 12/15/1978 CARDIAC CARE Q/C TEST KIT INSTRUMENTATION LABORATORY CO.
K781748 12/12/1978 IRRIGATION TRAY INTERMED, INC.
K781569 12/07/1978 NERVE LOCATER/STIMULATOR INTERMEDICS, INC.
K781738 12/07/1978 PACEMAKER, MODEL 229-01 INTERMEDICS, INC.
K781327 12/11/1978 PULSE GENERATOR, MODEL 240, EXTERNAL INTERMEDICS, INC.
K781678 12/12/1978 DEFIBRILLATOR, MARK II IPCO CORP.
K781679 12/12/1978 MONITOR/MINI SCOPE IPCO CORP.
K781962 12/20/1978 DIJI-DENT J&J TECHNOLOGIES, INC.
K781857 12/11/1978 TRAY, ARTERIAL BLOOD GAS SAMPLING JELCO LABORATORIES
K781952 12/07/1978 PAPER TAPE, HYPO ALLERGENIC JOHNSON & JOHNSON PROFESSIONALS, INC.
K781883 12/04/1978 DILUTER, LSA 290 PIPETTER KALLESTAD LABORATORIES, INC.
K781892 12/04/1978 LOCATOR, FOREIGN BODY KEELER OPTICAL PRODUCTS LTD.
K781987 12/04/1978 URINARY DRAINAGE BAG KELSAR CORP.
K781688 12/20/1978 LINER, CAVITY CALCIUM HYDROXIDE KERR CORPORATION (DANBURY)
K781796 12/07/1978 BEDDING, DISPOSABLE HOSPITAL KIMBERLY-CLARK CORP.
K781944 12/29/1978 STOCKINETTE KIMBERLY-CLARK CORP.
K781682 12/20/1978 SURGICAL GOWNS & DRAPES KIMBERLY-CLARK CORP.
K782002 12/15/1978 TRACH-COLLAR KINETIC CONCEPTS, INC.
K781913 12/04/1978 INSUFFALATOR LAPARAOSCOPIC KLI
K781977 12/20/1978 APPLICATOR, LEE IMPRESSION LEE PHARMACEUTICALS
K782016 12/13/1978 SPIROCARE 108-B MARION LABORATORIES, INC.
K782006 12/15/1978 MEDGENERAL SINGLE-USE BULLDOG MED GENERAL
K780430 12/22/1978 LITHICRON F PROGRAMMABLE PULSE GEN MEDCOR, INC.
K781780 12/07/1978 CATHETER, EXTERNAL MALE NURSING CARE MEDI-TECH, INC.
K781641 12/07/1978 SURGITEK DOUBLE "J" URETEROL STENT MEDICAL ENGINEERING CORP.
K781795 12/15/1978 DIALYZER, PARALLEL FLOW DISPOSABLE MEDICAL, INC.
K781981 12/07/1978 DECONTAMINATION ITEMS BAG MEDICARE INDUSTRIES, INC.
K781980 12/07/1978 RESPIRATORY THERAPY GAS POUCH MEDICARE INDUSTRIES, INC.
K781742 12/04/1978 INHAMATIC 33 MEDIMATIC
K782060 12/20/1978 MULTIFORMAT FILM CASSETTE TRANSPORT MEDISCAN, INC.
K782120 12/27/1978 SPONGE SYSTEM, ROSERING CONTAIN-COUNT MEDLINE INDUSTRIES, INC.
K782108 12/29/1978 MEDTRONIC MODEL 546 MEDTRONIC VASCULAR
K782047 12/20/1978 PROCESSING SYSTEM, A2 IMAGE MEDTRONIC VASCULAR
K782075 12/14/1978 STIMULATOR, MODEL 7727 MEDTRONIC VASCULAR
K781986 12/13/1978 TRANSMITTER, MODEL 9406 AND 9401 MEDTRONIC VASCULAR
K781802 12/20/1978 WASHER SYSTEM, MICROELISA METRIX TEKNIKA, INC.
K781835 12/21/1978 PULSTRON MODEL 100 MICRO-REL
K781549 12/07/1978 TOXELISA TEST KIT MICROBIOLOGICAL ASSOC.
K781878 12/29/1978 LIGHT, INSIDE MIDWEST
K781974 12/28/1978 IMPLANT DRIVERS AND TIPS MITER, INC.
K781032 12/15/1978 AQUA-GEL MURRAY, SALK, INC.
K782152 12/26/1978 VALVE, AMBU PEEP NARCO AIR-SHIELDS
K781665 12/15/1978 TUBE, LEATHERMAN/IMBRUCE NATIONAL CATHETER CO. DIV. MALLINCKRODT
K781744 12/07/1978 IV SET WITH GRADUATED CHAMBER NATIONAL PATENT DEVELOPMENT CORP.
K781810 12/20/1978 ELECTROSURGICAL UNIT 3001-3009 NEOMED CORP.
K781862 12/20/1978 BLOOD GROUP SUBSTANCE A NORTH AMERICAN BIOLOGICALS, INC.
K781896 12/20/1978 BLOOD GROUP SUBSTANCE A,B NORTH AMERICAN BIOLOGICALS, INC.
K781895 12/20/1978 BLOOD GROUP SUBSTANCE B NORTH AMERICAN BIOLOGICALS, INC.
K781713 12/12/1978 ADAPTER, C/D SUCTION NOVAMETRIX MEDICAL SYSTEMS, INC.
K781694 12/04/1978 PEN, MARK-3 SKIN MARKING FOUNTAIN OMEGA MARK-3 PEN CORP.
K781860 12/04/1978 ASSAY, CHROMOGENIC ANTITHROMBIN III ORTHO DIAGNOSTICS, INC.
K781638 12/20/1978 RUBINDEX*DIRECT SYSTEM ORTHO DIAGNOSTICS, INC.
K781917 12/04/1978 MUCUS ASPIRATOR OVUTIME, INC.
K781880 12/04/1978 ASSAY KIT, THROMBO-SCREEN PACIFIC HEMOSTASIS
K781351 12/04/1978 AURO-BRUSH PARKER LABORATORIES, INC.
K781820 12/07/1978 GLOVES, VINYL EXAMINATION PHOENIX GLOVE CO.
K781622 12/08/1978 PACING LEAD ADAPTER MODEL ACS 16 R.E. BROWN CO., INC.
K781627 12/08/1978 PACING LEAD ADAPTER MODEL ADB 21 R.E. BROWN CO., INC.
K781626 12/08/1978 PACING LEAD ADAPTER, ACV 14, ACV 23 R.E. BROWN CO., INC.
K781624 12/21/1978 PACING LEAD MODEL BUS 860, BUS 890 R.E. BROWN CO., INC.
K781625 12/08/1978 PACING LEAD MODEL MVM 860, MVM 890 R.E. BROWN CO., INC.
K781619 12/08/1978 PACING LEAD MODELS SA, 350, SAM 500 R.E. BROWN CO., INC.
K781621 12/08/1978 PACING LEAD MODELS, MAM 1260 MAM 1290 R.E. BROWN CO., INC.
K781620 12/08/1978 PACING LEAD MODELS, MDM 1060, MDM 1090 R.E. BROWN CO., INC.
K781623 12/08/1978 PACING MODELS MUM 860, MUM 890 R.E. BROWN CO., INC.
K781594 12/04/1978 DENTAL WARM WATER IRRIGATING SYSTEM RAMA CORP.
K781967 12/07/1978 HEMODIALYSIS CONCENTRATE, SODIU RENAL SYSTEMS, INC.
K781817 12/04/1978 OVU-GUIDE REPRODUCTION RESEARCH LABORATORIES
K781769 12/04/1978 IRON 59 KIT RIA PRODUCTS, INC.
K782074 12/21/1978 VENTILATOR, MODEL AVA-1, ADULT RULE MEDICAL INSTRUMENTS, INC.
K781701 12/04/1978 BLOOD PRESSURE, DIGITAL MODEL #2153 SEARS, ROEBUCK & CO.
K781733 12/20/1978 RIA KIT, PREG-STAT SERONO LABORATORIES, INC.
K781990 12/04/1978 CARDIAC INSULATION PAD SHILEY, INC.
K781991 12/07/1978 ANGIOSKIP SIEMENS CORP.
K781984 12/04/1978 COLLIMATOR, HEART CONTOUR SIEMENS CORP.
K781983 12/04/1978 EXPLORAMAT, COSMIC 2 SIEMENS CORP.
K781992 12/07/1978 KOORDINAT ANGIO SIEMENS CORP.
K781893 12/20/1978 CONTROL, PROTEIN ELECTROPHORESIS SIGMA CHEMICAL CO.
K781859 12/04/1978 REAGENT SYSTEM, NO 46-OV FOR CPK SIGMA CHEMICAL CO.
K781836 12/04/1978 TELEMETRY SYSTEM, BIOTEL 300 SPACELABS, INC.
K781927 12/20/1978 HUMAN II LENS SPECTRA-SHIELD, INC.
K781865 12/04/1978 IRON BINDING CAPICITY MODEL 0370 STANBIO LABORATORY
K781828 12/04/1978 COMPUTER, 3500, GILFORD SYSTEM SYVA CO.
K782097 12/22/1978 ELECTRODE LEAD MODEL 030-198 TELECTRONICS, INC.
K781849 12/04/1978 ELECTRODES, IMPLANTABLE WITH ADAPTER TELECTRONICS, INC.
K781158 12/18/1978 ALARM UNIT, BATTERY OPERATED THOMPSON RESPIRATION PRODUCTS, INC.
K781161 12/11/1978 RESPIRATOR, BANTAM MODEL THOMPSON RESPIRATION PRODUCTS, INC.
K781160 12/13/1978 VENTILATOR, MINILUNG THOMPSON RESPIRATION PRODUCTS, INC.
K781159 12/12/1978 VENTILATOR, PRESSURE THOMPSON RESPIRATION PRODUCTS, INC.
K781743 12/01/1978 RESPONSE SYSTEM, TN-3000 TRACOR INSTRUMENTS, INC.
K781704 12/01/1978 STIMULATOR, TN-3001 SOMATOSENSORY TRACOR INSTRUMENTS, INC.
K781812 12/07/1978 SOLUTION ADMINISTRATION, FLEX VALVE TRAVENOL LABORATORIES, S.A.
K781405 12/07/1978 SUITCASE KIDNEY HEMODIALYSIS SYSTEM UNION CARBIDE CORP.
K781616 12/08/1978 OMNI STIK UNITRON CORP.
K781882 12/28/1978 MODULAT DENTAL SYSTEMS VACUDENT SALES CORP.
K781637 12/12/1978 MODEL IV 1500 STANDARD BURETTE VALLEYLAB, INC.
K780960 12/07/1978 SERUM, CONTROL, DRUGS, ANTIARRYTHMIC VITEK SYSTEMS, INC.
K780961 12/07/1978 THEOPHYLLINE CONTROL SERUM VITEK SYSTEMS, INC.
K781787 12/20/1978 ISOPLAST VIVADENT (USA), INC.
K781899 12/20/1978 UREA NITROGEN TEST WAKO INTL., INC.
K781687 12/04/1978 AUROFIL WALLACE A. ERICKSON & CO.
K781794 12/29/1978 BETA-TEC WAMPOLE LABORATORIES
K781437 12/05/1978 SURGICAL PREP RAZOR WARREN J. GROSJEAN
K781989 12/15/1978 OMNIPREP WEAVER & CO.
K781788 12/28/1978 GOLD, 24 KARAT CASTING WILLIAMS GOLD REFINING CO., INC.


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