FDA 510(k) Applications Received During October, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K781770 10/16/1978 SKIN MARKING PEN ABCO DEALERS, INC.
K781727 10/11/1978 CHANGE IN STERILIZATION PROCEDURE ABSORBENT COTTON CO., INC.
K781841 10/27/1978 BAR, DISTRACTION ACE ORTHOPEDIC MANUFACTURING CO.
K781839 10/27/1978 BONE CLAMP, ACE EXTERNAL ACE ORTHOPEDIC MANUFACTURING CO.
K781840 10/27/1978 EXTERNAL ARTICULATION ACE ORTHOPEDIC MANUFACTURING CO.
K781832 10/30/1978 SCALE, ACME DIGITAL BEDSIDE ACME MEDICAL SCALE CO.
K781672 10/03/1978 ACU-DOT ACU-DOT PHARMACEUTICAL INTL., INC.
K781765 10/16/1978 LDH REAGENT SYSTEM AMERICAN MONITOR CORP.
K781699 10/11/1978 EAGLE PAC/VISIBLE SEAL AMERICAN STERILIZER CO.
K781698 10/10/1978 EXAMINER 10 AMERICAN STERILIZER CO.
K781684 10/02/1978 STERILIZER, EAGLE 2000 AMERICAN STERILIZER CO.
K781685 10/04/1978 RIA KIT, LH AMERSHAM CORP.
K781728 10/06/1978 EXTUBE ANALYTICHEM INTERNATIONAL, INC.
K781750 10/16/1978 MIRROR WARMER ARLETON TECHNICAL PRODUCTS, INC.
K781848 10/23/1978 PUMP, BALLOON MODEL 10 AVCO MEDICAL PRODUCTS
K781816 10/27/1978 INOCULATOR, AIM-4 MICROPROCESSOR AXFORD MANUFACTURING LTD.
K781749 10/17/1978 TUBING, AXIOM SILICONE PENROSE AXIOM MEDICAL, INC.
K781731 10/12/1978 INCENT-O-NEB B & F MEDICAL PRODUCTS, INC.
K781793 10/25/1978 FRAME, UNIVERSAL DAY B.G. ORTHOPEDIC CORP.
K781800 10/23/1978 GRIP, HOSPITAL UTILITY BAKA MANUFACTURING CO., INC.
K781674 10/03/1978 MACRO-VUE TEST, GENTAMICIN BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781669 10/03/1978 RESPIRATORY EXERCISOR, VOLUME PULSE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K781842 10/27/1978 OXYGENATOR, BLOOD BOS-10 BENTLEY LABORATORIES, INC.
K781786 10/19/1978 QUANTICEL HHR # L500 AND L501 BHP DIAGNOSTIX, INC.
K781745 10/20/1978 QUANTICEL HHR, L531 AND L532 BHP DIAGNOSTIX, INC.
K781757 10/16/1978 SERACON-SRI BHP DIAGNOSTIX, INC.
K781758 10/16/1978 SERACON-SRII BHP DIAGNOSTIX, INC.
K781683 10/02/1978 NURITE II, SINGLE BIO-MEDICAL SYSTEMS CORP.
K781702 10/10/1978 CALIBRATOR, BOVINE SERUM BIO-REAGENTS & DIAGNOSTICS, INC.
K781799 10/23/1978 EKG, SWITCHING BLADE AND PENS BIONEX, INC.
K781734 10/12/1978 SODIUM CHLORIDE, 0.85% BIOSCIENTIFIC
K781691 10/04/1978 CHEMSTRIP CONTROL BOEHRINGER MANNHEIM CORP.
K781760 10/16/1978 HUMIDIFIERS, MODEL:LS-420 AND LS-460 BOURNS MEDICAL SYSTEMS, INC.
K781681 10/02/1978 PHIPIOLOGICAL SYNCHRONIZER PART#205 BRATTLE INSTRUMENT CORP.
K781838 10/27/1978 CALCULATOR, WITH CHARGER C.R. BARD, INC.
K781736 10/12/1978 DISC, COLOPLAST PRE-OP STOMA C.R. BARD, INC.
K781767 10/16/1978 INSTRUMENT CURNETT MINI-CONER BIOPSY C.R. BARD, INC.
K781766 10/16/1978 UTERINE SOUND, BURNETT DISPOSABLE C.R. BARD, INC.
K781746 10/18/1978 MINICO CATALYST RESEARCH CORP.
K781706 10/10/1978 RESPIRATOR/GILL 1/SIMV CHEMETRON MEDICAL PRODUCTS, INC.
K781833 10/30/1978 EXERCISER, AIR-EZE INCENTIVE CHESEBROUGH-POND'S U.S.A. CO.
K781807 10/25/1978 REAGENT, FIREFLY #395 CHRONO-LOG CORP.
K781764 10/16/1978 PAD, COOLING #27-999 COBE LABORATORIES, INC.
K781785 10/18/1978 I.V. SET WITH IN-LINE FILTER CUTLER LABORATORIES, INC.
K781671 10/03/1978 BLOOD PRESSURE CUFF COVER DAVID COTT CO.
K781777 10/13/1978 ABRASIVE WHEELS DENTSPLY INTL.
K781754 10/17/1978 SPLINT, HOAKE INFLATABLE AIR DEPUY, INC.
K781791 10/20/1978 BOARD, DISPOSABLE CONTROL COUNT DEXIDE, INC.
K781710 10/05/1978 BUFFER, COLLAGEN REAGENT AND DILUENT DIAGNOSTICA, INC.
K781759 10/16/1978 RESCAL DIEMOLDING CORP.
K781756 10/16/1978 SILASTIC H.P. TRAPEXIAL IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K781755 10/17/1978 DAP-PAK DRAVON MEDICAL, INC.
K781716 10/05/1978 BLADE, 20 ANGLE/MICRO BLADE HOLDER EDWARD WECK, INC.
K781715 10/05/1978 RULER, WECK SCOTT EDWARD WECK, INC.
K781670 10/03/1978 STIMULATOR, E.S.I. NEURO EVOLUTIONARY SYSTEMS, INC.
K781690 10/04/1978 L-CYSTEINE HYDROCHLORIDE FISHER SCIENTIFIC CO., LLC.
K781740 10/17/1978 REAGENT, HDL FISHER SCIENTIFIC CO., LLC.
K781781 10/19/1978 HEPARSORB GENERAL DIAGNOSTICS
K781814 10/26/1978 SULFATE, FIBRIQUIK PROTAMINE GENERAL DIAGNOSTICS
K781673 10/03/1978 MAXI-CAMERA 535 GENERAL ELECTRIC CO.
K781773 10/13/1978 ALBUMIN REAGENT GILFORD DIAGNOSTICS
K781784 10/19/1978 AST GILFORD DIAGNOSTICS
K781783 10/19/1978 BLOOD SUGAR GILFORD DIAGNOSTICS
K781782 10/19/1978 BUN GILFORD DIAGNOSTICS
K781775 10/13/1978 LDH GILFORD DIAGNOSTICS
K781774 10/13/1978 TOTAL PROTEIN GILFORD DIAGNOSTICS
K781815 10/24/1978 HEMO-NATE SYRINGE BLOOD FILTER GISCO INTL.
K781771 10/13/1978 DETECTOR, MODEL 79875A, VARIABLE HEWLETT-PACKARD CO.
K781768 10/16/1978 CATHETERS, H-H ATRIAL AND PERITONEAL HOLTER-HAUSNER INTL.
K781693 10/04/1978 COLLAGENREAGENT "HORM" HORMON-CHEMIE MUNCHEM GMCH
K781762 10/16/1978 COMPRESSION HIP SCREW SYSTEM HOWMEDICA CORP.
K781792 10/25/1978 PRESSURIZER, EXETER CEMENT HOWMEDICA CORP.
K781837 10/30/1978 WOUND SPAN BRIDGE III HOWMEDICA CORP.
K781831 10/30/1978 SPIROMETER, INCENTIVE CATALOG # 1750 HUDSON OXYGEN THERAPY SALES CO.
K781741 10/07/1978 MASK, BI FLO NASAL OXYGEN INHAL-O-TECH MEDICAL PLASTIC
K781748 10/17/1978 IRRIGATION TRAY INTERMED, INC.
K781738 10/17/1978 PACEMAKER, MODEL 229-01 INTERMEDICS, INC.
K781678 10/02/1978 DEFIBRILLATOR, MARK II IPCO CORP.
K781679 10/02/1978 MONITOR/MINI SCOPE IPCO CORP.
K781688 10/04/1978 LINER, CAVITY CALCIUM HYDROXIDE KERR CORPORATION (DANBURY)
K781689 10/04/1978 REFLECT IMPRESSION MATERIAL KERR CORPORATION (DANBURY)
K781796 10/25/1978 BEDDING, DISPOSABLE HOSPITAL KIMBERLY-CLARK CORP.
K781682 10/02/1978 SURGICAL GOWNS & DRAPES KIMBERLY-CLARK CORP.
K781751 10/16/1978 CATHETER, AKRON FOLEY TEFLON LATEX IND., INC.
K781700 10/10/1978 IONOTPHORETIC APPLICATOR MCGHAN MEDICAL CORP.
K781818 10/27/1978 LAPARATOMY SPONGE MEDEN MEDICAL SALES DIVISION
K781761 10/16/1978 KENDRICK EXTRICATION DEVICE MEDI-KED, INC.
K781780 10/18/1978 CATHETER, EXTERNAL MALE NURSING CARE MEDI-TECH, INC.
K781772 10/16/1978 CATHETER, TRANSLUMINAL BALLOON MEDI-TECH, INC.
K781718 10/11/1978 ALP REAGENT SET, ALKALINE PHOSPHATASE MEDICAL ANALYSIS SYSTEMS, INC.
K781719 10/11/1978 CPK REAGENT SET, NAD REDUCTION MEDICAL ANALYSIS SYSTEMS, INC.
K781723 10/11/1978 GLUCOSE HEXOKINASE, AUTO K MEDICAL ANALYSIS SYSTEMS, INC.
K781720 10/11/1978 HBDH ENZYME KINETIC REAGENT SET MEDICAL ANALYSIS SYSTEMS, INC.
K781724 10/11/1978 NAD REDUCTION METHOD, LACTATE PYRIVATE MEDICAL ANALYSIS SYSTEMS, INC.
K781721 10/11/1978 REAGENT SET, CHOLESTEROL MEDICAL ANALYSIS SYSTEMS, INC.
K781726 10/11/1978 REAGENT SET, SGPT SERUM GLUTAMIC MEDICAL ANALYSIS SYSTEMS, INC.
K781722 10/11/1978 REAGENT SET, TOTAL PROTEIN MEDICAL ANALYSIS SYSTEMS, INC.
K781725 10/11/1978 REAGENT SET, U.V. ENZMATIC KINETIC, SGOT MEDICAL ANALYSIS SYSTEMS, INC.
K781829 10/30/1978 NEUROPAC ULTRA II MEDICAL DEVICES, INC.
K781795 10/25/1978 DIALYZER, PARALLEL FLOW DISPOSABLE MEDICAL, INC.
K781742 10/17/1978 INHAMATIC 33 MEDIMATIC
K781819 10/27/1978 POST EXTRA SYSTOLIC POTENTIATOR MEDRAD, INC.
K781803 10/23/1978 FILTER, EYRPUR DISPOSABLE LEUKOCITE METRIX TEKNIKA, INC.
K781802 10/23/1978 WASHER SYSTEM, MICROELISA METRIX TEKNIKA, INC.
K781835 10/30/1978 PULSTRON MODEL 100 MICRO-REL
K781744 10/20/1978 IV SET WITH GRADUATED CHAMBER NATIONAL PATENT DEVELOPMENT CORP.
K781810 10/26/1978 ELECTROSURGICAL UNIT 3001-3009 NEOMED CORP.
K781713 10/06/1978 ADAPTER, C/D SUCTION NOVAMETRIX MEDICAL SYSTEMS, INC.
K781714 10/06/1978 PNEUMOGARD MODEL 1230 NOVAMETRIX MEDICAL SYSTEMS, INC.
K781696 10/10/1978 COPPER-TRAP OLYMPIC MEDICAL CORP.
K781695 10/10/1978 LUBE-LOK OLYMPIC MEDICAL CORP.
K781694 10/10/1978 PEN, MARK-3 SKIN MARKING FOUNTAIN OMEGA MARK-3 PEN CORP.
K781776 10/13/1978 PACING LEADS MODEL UL-811 AND UL-813 PACESETTER SYSTEMS
K781752 10/18/1978 SCANNER, CT 0450 PFIZER MEDICAL SYSTEMS, INC.
K781680 10/02/1978 MONITORING, PRESSURE KIT PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781797 10/23/1978 PREP TRAY, PREOPERATIVE SKIN PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781709 10/10/1978 SCANNER, LINEAR PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K781820 10/27/1978 GLOVES, VINYL EXAMINATION PHOENIX GLOVE CO.
K781808 10/23/1978 SLICK SET, CUFFED POLAMEDCO, INC.
K781730 10/13/1978 RIA, CORTISOL KIT RADIOASSAY SYSTEMS LABORATORIES, INC.
K781817 10/30/1978 OVU-GUIDE REPRODUCTION RESEARCH LABORATORIES
K781769 10/16/1978 IRON 59 KIT RIA PRODUCTS, INC.
K781737 10/12/1978 EXTRACTOR, SABIAN FOREIGN BODY SABIAN CORP.
K781701 10/10/1978 BLOOD PRESSURE, DIGITAL MODEL #2153 SEARS, ROEBUCK & CO.
K781733 10/13/1978 RIA KIT, PREG-STAT SERONO LABORATORIES, INC.
K781711 10/05/1978 EVALUSKOP SIEMENS CORP.
K781705 10/10/1978 MOBIL XR SIEMENS CORP.
K781806 10/25/1978 REAGENT SYSTEM, INORGANIC PHOSPHORUS SIGMA CHEMICAL CO.
K781836 10/30/1978 TELEMETRY SYSTEM, BIOTEL 300 SPACELABS, INC.
K781798 10/23/1978 TINNITUS MASKER STARKEY LABORATORIES, INC.
K781801 10/23/1978 MAXI-CHAIR SURGICAL MECHANICAL RESEARCH, INC.
K781707 10/10/1978 FILTER, ARTERIAL BLOOD W/TUBING BYPASS SURGIKOS, INC.
K781717 10/11/1978 MONITOR, GRAVITY IRRIGATION DRIP SYNTEL, INC.
K781828 10/30/1978 COMPUTER, 3500, GILFORD SYSTEM SYVA CO.
K781827 10/30/1978 CONTROL SET, EMIT METHOTREXATE SYVA CO.
K781822 10/27/1978 ELECTRODE, MODEL 030-324 TELECTRONICS, INC.
K781824 10/27/1978 ELECTRODE, MODEL 030-324/4 GUAGE TELECTRONICS, INC.
K781823 10/27/1978 ELECTRODE, MODEL 030-326 TELECTRONICS, INC.
K781849 10/27/1978 ELECTRODES, IMPLANTABLE WITH ADAPTER TELECTRONICS, INC.
K781697 10/10/1978 PRESSURE, LOW/HIGH MODEL C1070 TIMETER INSTRUMENT CORP.
K781753 10/17/1978 TOMOGSCANNER 2 TOMOGSCANNER OK LTD.
K781739 10/17/1978 CAMERA, GCA-10A, LOW ENERGY TOSHIBA MEDICAL SYSTEMS
K781729 10/10/1978 TRACHEOTOMY TUBES TRACOE MEDICAL GMBH
K781743 10/20/1978 RESPONSE SYSTEM, TN-3000 TRACOR INSTRUMENTS, INC.
K781704 10/10/1978 STIMULATOR, TN-3001 SOMATOSENSORY TRACOR INSTRUMENTS, INC.
K781812 10/26/1978 SOLUTION ADMINISTRATION, FLEX VALVE TRAVENOL LABORATORIES, S.A.
K781813 10/26/1978 SOLUTION ADMINISTRATION, TIP PROTECTOR TRAVENOL LABORATORIES, S.A.
K781811 10/26/1978 TRANSFER PAK 4R 9006 TRAVENOL LABORATORIES, S.A.
K781882 10/24/1978 MODULAT DENTAL SYSTEMS VACUDENT SALES CORP.
K781830 10/31/1978 BIOPSY KIT 781101, ASPIRATION VISTA PRODUCTS, INC.
K781787 10/19/1978 ISOPLAST VIVADENT (USA), INC.
K781735 10/12/1978 ENDOPROSTHESIS SYSTEM, VARIO-HEAD WALDEMAR LINK GMBH & CO. KG
K781687 10/03/1978 AUROFIL WALLACE A. ERICKSON & CO.
K781794 10/25/1978 BETA-TEC WAMPOLE LABORATORIES
K781692 10/04/1978 CALIBRATOR, DYNAMIC WATERS ASSOC., INC.
K781805 10/24/1978 CARDIAC COMPUTERS, CO-10 & CO-10R WATERS ASSOC., INC.
K781834 10/30/1978 TEST SET, 125 I-DIGOXIN WIEN LABORATORIES, INC.
K781788 10/19/1978 GOLD, 24 KARAT CASTING WILLIAMS GOLD REFINING CO., INC.


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