FDA 510(k) Applications Received During April, 1979

FDA 510(k) Number Submission Date Device Name Applicant Contact
K790654 04/05/1979 CLOSED WOUND VACUUM DRAINAGE SYSTEM 3M COMPANY
K790731 04/16/1979 OXYGEN HUMIDIFIER KIT ABBOTT LABORATORIES
K790633 04/03/1979 "ACCOR" MATRIX ACCOR, INC.
K790809 04/26/1979 VS, ANESTHESIA VENTILATOR AIRCO/OHIO MEDICAL PRODUCTS
K790797 04/24/1979 AMYLASE REAGENT SET ALTA DIAGNOSTICS, INC.
K790796 04/24/1979 LIPASE REAGENT SET ALTA DIAGNOSTICS, INC.
K790753 04/17/1979 DIMENSIONALL ROTATOR AMERICAN HOSPITAL SUPPLY CORP.
K790634 04/03/1979 IMPERVIOUS STERILE STOCKINETTE ANAGO, INC.
K790799 04/24/1979 PULPTESTER MODEL 2001 ANALYTIC TECHNOLOGY
K790770 04/20/1979 SAFETY HOLSTER, SINGLE-USE ASPEN LABORATORIES, INC.
K790835 04/30/1979 DYNAJECT ATOMIC PRODUCTS CORP.
K790635 04/02/1979 Q220F CARDITOMY RESERVOIR/MODIFIED BENTLEY LABORATORIES, INC.
K790769 04/19/1979 BETA/PAK BIO/DATA CORP.
K790762 04/17/1979 PLATFORM TCCK TOTAL KNEE BIOMET, INC.
K790772 04/20/1979 CHEMTAB BOEHRINGER MANNHEIM CORP.
K790694 04/10/1979 BRITT LENS COMPUTER BRITT CORP., INC.
K790754 04/17/1979 BROWNE MODEL CF-1 AND CF-1G BROWNE CORP.
K790773 04/20/1979 ENZYMATIC TRIGLYCERIDES-S.V.R. CALBIOCHEM-BEHRING CORP.
K790677 04/09/1979 EO EVACUATING SYSTEM I CASTLE CO.
K790784 04/23/1979 MODEL M25R, OXYGEN ANALYZER CATALYST RESEARCH CORP.
K790785 04/23/1979 MODEL M25RL, (CRC) OXYGEN ANALYZER CATALYST RESEARCH CORP.
K790836 04/30/1979 GUARDIAN II I.V. CONTROLLER CENTAUR SCIENCES, INC.
K790801 04/19/1979 STERILE DEFIBRINATED SHEEP BLOOD CENTRAL BIOLOGICAL CO.
K790631 04/03/1979 STERAID SURGICAL DRESSING CORDA INTL. HOLDINGS, INC.
K790690 04/10/1979 OMNI-STANICOR-(THETA) MODEL 217 CORDIS CORP.
K790667 04/06/1979 CORNING PARAPROTEIN SCREENING CORNING MEDICAL & SCIENTIFIC
K790812 04/26/1979 COULTER ACCU-ZYME IIY-GT REAGENT KIT COULTER ELECTRONICS, INC.
K790810 04/26/1979 DISPOSA-CUF CREST MEDICAL EQUIPMENT
K790776 04/20/1979 DADE LOW IONIC STRENGTH SOLUITION (LISS) DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790767 04/19/1979 IMMU-TEK AUTOMATIC CENTRIFUGE DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K790775 04/20/1979 INTRA-AORTIC BALLOON, TYPE S DATASCOPE CORP.
K790668 04/06/1979 VENOUS PRESSURE MONITOR, MF 35 LF DECO MEDICAL, INC.
K790756 04/17/1979 HEAT EXCHANGER COIL DELTA MEDICAL INDUSTRIES
K790774 04/20/1979 LODA WRIST PROSTHESIS DEPUY, INC.
K790672 04/06/1979 ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU DIAGNOSTICA, INC.
K790671 04/06/1979 DERMATOPHYTIN "O" DIAGNOSTICA, INC.
K790728 04/13/1979 "TOUCHLESS TM" FOLEY CATHETER KIT DIAMED DIVISION ILL. TOOL WORKS, INC.
K790670 04/06/1979 PULSE GENERATOR MODEL 629 ELEMA-SCHONANDER, INC.
K790792 04/24/1979 PULSE GENERATOR MODEL 637 ELEMA-SCHONANDER, INC.
K790794 04/24/1979 SIEMENS CARDIOSTAT 701 ELMED, INC.
K790744 04/16/1979 LUNG FUNCTION AMPLIFIER EXERCISER EMPIRE PLASTICS MANUFACTURER
K790832 04/30/1979 KETAC APPLIC-CAPSULES ESPE GMBH (US)
K790833 04/30/1979 VISIO-BOND ESPE GMBH (US)
K790791 04/24/1979 ELECTROPHORESIS REAGENT SET, HDL GELMAN SCIENCES, INC.
K790692 04/10/1979 TELEVIX GENERAL ELECTRICAL ESPANOLA, S.A.
K790816 04/27/1979 HEMATRAK MODEL 480 GEOMETRIC DATA, DIV. SMITHKLINE CORP.
K790687 04/10/1979 BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K790786 04/23/1979 GLUCOSE (HK) REAGENT GILFORD DIAGNOSTICS
K790771 04/20/1979 LD-P REAGENT (LDH P-L REAGENT) GILFORD DIAGNOSTICS
K790818 04/27/1979 MEDI-TRACE EEG CREME GRAPHIC CONTROLS CORP.
K790807 04/24/1979 METALIT HARRY J. BOSWORTH CO.
K790806 04/24/1979 PORCELIT HARRY J. BOSWORTH CO.
K790737 04/16/1979 HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID HEARING SERVICES, INC.
K790826 04/30/1979 COAGULATION ARP HELENA LABORATORIES
K790798 04/17/1979 FETAL MATURITY TEST PROCEDURE HELENA LABORATORIES
K790655 04/05/1979 ABUSCREEN RIA FOR PHENCYCLIDINE HOFFMANN-LA ROCHE, INC.
K790825 04/30/1979 LS-8 VISICORDER HONEYWELL, INC.
K790827 04/20/1979 RP-610 PARALLEL PLATE DIALYZER HOSPAL MEDICAL CORP.
K790793 04/24/1979 AMC "R" METACARPAL COMPONENT HOWMEDICA CORP.
K790811 04/26/1979 EXETER BONE LAUAGE SYSTEM HOWMEDICA CORP.
K790675 04/09/1979 5300 PERCUSSOR HUDSON OXYGEN THERAPY SALES CO.
K790659 04/04/1979 INFANT SCALE DISPOSABLE LINER HYDRO-MED PRODUCTS, INC.
K790693 04/10/1979 HYPERBARIC OXYGEN CHAMBER HYPERBARIC OXYGEN THERAPY, INC.
K790831 04/30/1979 ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST ICL SCIENTIFIC
K790669 04/06/1979 DROP CONTROLLER IMED CORP.
K790674 04/09/1979 "THE SURGICAL ASSISTANT" INSTRUMENT MAKAR, INC.
K790650 04/03/1979 WEISS EMERGENCY AIRWAY SYSTEM INTL. MEDICAL DEVICES LTD.
K790738 04/16/1979 HABITSABATER JACKSON ENT.
K790711 04/12/1979 ANTISERA TO HUMAN FRAGMENT KENT LABORATORIES, INC.
K790720 04/12/1979 ANTISERA TO RABBIT IMMUNOGLOBULIN KENT LABORATORIES, INC.
K790710 04/12/1979 ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN KENT LABORATORIES, INC.
K790716 04/12/1979 ANTISERUM TO HUMAN C-REACTIVE PROTEINS KENT LABORATORIES, INC.
K790714 04/12/1979 ANTISERUM TO HUMAN CERULOPLASMIN KENT LABORATORIES, INC.
K790715 04/12/1979 ANTISERUM TO HUMAN FC KENT LABORATORIES, INC.
K790713 04/12/1979 ANTISERUM TO HUMAN HEMOPEXIN KENT LABORATORIES, INC.
K790708 04/12/1979 ANTISERUM TO HUMAN IG G FC FRAGMENTS KENT LABORATORIES, INC.
K790704 04/12/1979 ANTISERUM TO HUMAN IGG KENT LABORATORIES, INC.
K790705 04/12/1979 ANTISERUM TO HUMAN IGM KENT LABORATORIES, INC.
K790712 04/12/1979 ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI KENT LABORATORIES, INC.
K790706 04/12/1979 ANTISERUM TO RABBIT IGG H & L CHAIN KENT LABORATORIES, INC.
K790709 04/12/1979 ANTISERUM TO RABBIT IMMUNOGLOBULIN KENT LABORATORIES, INC.
K790703 04/12/1979 ANTISERUM, HUMAN, IGA KENT LABORATORIES, INC.
K790702 04/12/1979 ANTISERUM, HUMAN, IGG H & L CHAIN KENT LABORATORIES, INC.
K790636 04/02/1979 KIMLON UNIVERSAL DRAPE KIMBERLY-CLARK CORP.
K790664 04/06/1979 MODEL 1309 AUDIO MONITOR LIFE-TECH INSTRUMENTS, INC.
K790663 04/06/1979 MODEL 1750 STANDING URINAL LIFE-TECH INSTRUMENTS, INC.
K790726 04/13/1979 BEHIND-THE-EAR HEARING INSTRUMENT, H54 MARCON HEARING INSTRUMENTS, INC.
K790700 04/12/1979 BEHIND-THE-EAR HEARING INSTRUMENT, H56 MARCON HEARING INSTRUMENTS, INC.
K790727 04/13/1979 BEHIND-THE-EAR, MODEL H37D MARCON HEARING INSTRUMENTS, INC.
K790779 04/23/1979 MODEL H39C-BEHING-THE-EAR HEARING INSTRU MARCON HEARING INSTRUMENTS, INC.
K790697 04/10/1979 MODEL H58-BEHIND-THE-EAR HEARING INSTR. MARCON HEARING INSTRUMENTS, INC.
K790815 04/27/1979 CULTURETTE BRAND PVA MARION LABORATORIES, INC.
K790763 04/18/1979 MAXI-VAC TM MED GENERAL
K790759 04/17/1979 IIF-APCA TEST KIT MEDICA CORP.
K790691 04/10/1979 25-50 EKG RULER MEDICAL ENGINEERING DESIGNS CO., INC.
K790758 04/17/1979 HEMOCLEAR U-NEPHROS 1.0 DIALYZER MEDICAL, INC.
K790803 04/25/1979 SYRINGE TONOMETER MEDICOR USA LTD.
K790766 04/19/1979 MEDTRONIC MODELS 6907/6901 MEDTRONIC VASCULAR
K790790 04/24/1979 PISCES-SELECTOR X MEDTRONIC VASCULAR
K790665 04/06/1979 NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM MICROMEDIC SYSTEMS
K790732 04/16/1979 VENTIMETER CONTROLLER NARCO AIR-SHIELDS
K790733 04/16/1979 VENTIMETER VENTILATOR NARCO AIR-SHIELDS
K790730 04/13/1979 NDM PAPER TAPE ECG ELECTRODE NDM CORP.
K790817 04/27/1979 RIA KIT, QUANTITATION OF PROSTATIC ACID NEW ENGLAND NUCLEAR
K790653 04/05/1979 NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER NOVA CORP.
K790673 04/09/1979 OMNIMEDICAL AUTOMATIC 1001 OMNIMEDICAL
K790734 04/16/1979 PREGNOSTICON PREGNANCY TEST KIT ORGANON, INC.
K790813 04/27/1979 MULTECON BLOOD GAS CONTROL ORTHO DIAGNOSTICS, INC.
K790729 04/12/1979 OCTAGONAL ALUMINUM FRAMING SYSTEM ORTHOPEDIC SYSTEMS, INC.
K790740 04/16/1979 BS 66, UNIVERSAL BUCKY STAND PAUSCH CORP.
K790741 04/16/1979 COMPACT SYSTEM PAUSCH CORP.
K790743 04/16/1979 COORDINATUS, HORIZONTAL RADIOGRAPHOC PAUSCH CORP.
K790742 04/16/1979 KS-78 VERTICAL WALL CASSETTE HOLDER PAUSCH CORP.
K790757 04/17/1979 LIFEPAK 5 MONITOR, CASSETTE, #800923-01 PHYSIO-CONTROL CORP.
K790637 04/02/1979 COMPUTERIZED ELECTRO-OCULOGRAPH POTOMAC MEDICAL SYSTEM
K790739 04/16/1979 QUINTON MODEL 530X ECG DATA CART QUINTON, INC.
K790696 04/10/1979 RDI-1 HOLLOW FIBER DIALYZER RENAL DEVICES, INC.
K790661 04/02/1979 PROTECTOR II RICHARD-ALLAN MEDICAL IND., INC.
K790660 04/02/1979 SURGICAL RULER RICHARD-ALLAN MEDICAL IND., INC.
K790682 04/11/1979 TONOTEST BLOOD PRESSURE DEVICE ROBERT BOSCH CORP.
K790761 04/17/1979 FETASONDE MODEL 2108 ROCHE MEDICAL ELECTRONICS, INC.
K790684 04/11/1979 COLOR CODING OF SURGICAL INSTRUMENTS SARA DAN, INC.
K790789 04/24/1979 COMPOSITE RESTORATIVE, PASTE/PASTE TYPE SCIENTIFIC PHARMACEUTICALS, INC.
K790788 04/24/1979 FISSURE SEALER AND BONDING AGENT SCIENTIFIC PHARMACEUTICALS, INC.
K790746 04/16/1979 THE "BIONIC EXERCISER" SCUDDER MOLNER INSTRUMENTS
K790679 04/09/1979 ESTRADIOL RIA KIT SERONO LABORATORIES, INC.
K790783 04/23/1979 KOORDINAT 3D SIEMENS CORP.
K790765 04/19/1979 MULTIGRAPH SIEMENS CORP.
K790681 04/10/1979 SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150 SIEMENS CORP.
K790688 04/10/1979 MEVATRON 67 SIEMENS MEDICAL LABORATORIES, INC.
K790747 04/16/1979 MEVATRON 74 SIEMENS MEDICAL LABORATORIES, INC.
K790724 04/13/1979 ENZYMATIC DETERMINATION SIGMA CHEMICAL CO.
K790760 04/17/1979 REAGENT SYSTEM #350HDL, SIGMA PROCEDURE SIGMA CHEMICAL CO.
K790755 04/17/1979 SMEC BALLOON CANNULA SMEC, INC.
K790678 04/09/1979 INTRAUTERINE CATHETER TIP SONICAID, INC.
K790837 04/30/1979 ARRHYTHMIA II CARDULE SPACELABS, INC.
K790808 04/26/1979 PROTEIN ASSAY KIT SPECIALTY MEDICAL INDUSTRIES, INC.
K790814 04/27/1979 DELTA PUMP SPIESS DESIGN, INC.
K790651 04/03/1979 MODEL WC-3 HEARING AID STARKEY LABORATORIES, INC.
K790745 04/16/1979 _MODEL WC-1 BEHIND-THE-EAR HEARING AID STARKEY LABORATORIES, INC.
K790802 04/25/1979 ESSAR TOURNIQUET FOR VENIPUNCTURE STEWART RESEARCH, INC.
K790725 04/13/1979 BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* SURGIKOS, INC.
K790804 04/24/1979 PURGE LINE UNIT SURGIKOS, INC.
K790686 04/11/1979 EMIT CFA THYROXINE ASSAY SYVA CO.
K790829 04/30/1979 EMIT GENTAMICIN ASSAY SYVA CO.
K790830 04/30/1979 EMIT GENTAMICIN CONTROL SYVA CO.
K790736 04/16/1979 EMIT-TOX SERUM BENZODIAZEPINE ASSAY SYVA CO.
K790735 04/16/1979 EMIT-TOX SERUM CALIBRATORS SYVA CO.
K790805 04/25/1979 DRUG ABUSE DIPSTICKS TECHNICAL RESOURCES, INC.
K790699 04/12/1979 TECNOL BODY HOLDER TECNOL NEW JERSEY WOUND CARE, INC.
K790764 04/19/1979 PACEMAKERS WITHOUT SILASTIC COATING TELECTRONICS, INC.
K790834 04/30/1979 UV URIC ACID DETERMINATION THE DOW CHEMICAL CO.
K790795 04/24/1979 MODEL 4000, SPECTROPHOTOMETER THE PERKIN-ELMER CORP.
K790652 04/04/1979 TOGUARD TOGARD, INC.
K790662 04/06/1979 CENTRIFICHEM INORGANIC PHOSPHORUS UNION CARBIDE CORP.
K790750 04/17/1979 COLOSTOMY DEVICE W/ PRESSURE LID VABAR CORP.
K790749 04/17/1979 COLOSTOMY ENEMA DEVICE VABAR CORP.
K790780 04/23/1979 ATOMIC ABSORPTION SPECTROPHOTOMETER, VARIAN ASSOC., INC.
K790781 04/23/1979 SPECTROPHOTOMETER SYSTEM, MODEL AA-475 VARIAN ASSOC., INC.
K790800 04/24/1979 CENTRIA T4 RIA TEST SET VENTREX LABORATORIES, INC.
K790658 04/05/1979 AIRCRAFT TRANSIT ISOLATOR MODEL 121 VICKERS AMERICA MEDICAL CORP.
K790689 04/10/1979 REVISED BATTERY CHARGER VICKERS AMERICA MEDICAL CORP.
K790657 04/05/1979 STRETCHER TRANSIT ISOLATER #122 VICKERS AMERICA MEDICAL CORP.
K790685 04/11/1979 POSI-TOT VICTOREEN, INC.
K790666 04/06/1979 VITALITH S 3000 SERIES VITATRON MEDICAL BV
K790768 04/19/1979 WAKO CHOLESTEROL TEST WAKO INTL., INC.
K790722 04/10/1979 PROPHYLAXIS ANGLE YOUNG DENTAL MANUFACTURING CO 1, LLC.
K790723 04/10/1979 PROPHYLAXIS CUPS AND POLISHERS YOUNG DENTAL MANUFACTURING CO 1, LLC.


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