FDA 510(k) Decisions During June, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K780942 06/19/1978 BLOOD PUMP MODEL 7000 3M HEALTH CARE, SARNS
K780880 06/30/1978 Y-TYPE BLOOD SET ABBOTT LABORATORIES
K780597 06/28/1978 ECG PAPER, 3 CHANNEL ABCO DEALERS, INC.
K780613 06/02/1978 ENEMA, PHOSPHATE ABCO DEALERS, INC.
K780795 06/06/1978 GAUZE SPONGES ABCO DEALERS, INC.
K780608 06/06/1978 ICE BAG, VINYL ABCO DEALERS, INC.
K780806 06/22/1978 LAPOROTOMY SPONGE ABCO DEALERS, INC.
K780607 06/22/1978 MASK, SURGEONS ABCO DEALERS, INC.
K780593 06/06/1978 PROBE COVER ABCO DEALERS, INC.
K780598 06/06/1978 TREND II ANEROID ABCO DEALERS, INC.
K780594 06/06/1978 VELKET TOURNIQUET ABCO DEALERS, INC.
K780876 06/27/1978 ULTRASONIC IMAGER AIR-SHIELDS, INC.
K780979 06/30/1978 AIRSTIRRUP PNEUMATIC ANKLE BRACE AIRCAST, INC.
K780791 06/13/1978 SGPT/ALT REAGENT SYSTEM AMERICAN MONITOR CORP.
K780497 06/14/1978 SPHERISTEM TOTAL HIP PROSTHESIS AMERICAN ORTOMED CORP.
K780726 06/13/1978 TSH RIA KIT AMERSHAM CORP.
K780799 06/13/1978 VITAMIN B12 RADIOASSAY AMERSHAM CORP.
K780971 06/22/1978 CLINICAL ACQUISITION MODULE ANALYTICAL DEVELOPMENT ASSOC. CORP.
K780908 06/19/1978 SELF-RETAINING ELECTRODE SER. #4000-100 ANDOVER MEDICAL, INC.
K780754 06/14/1978 NEONATAL MONITOR APPLIED MEDICAL RESEARCH
K780835 06/22/1978 ARANTROL ARANCO DIAGNOSTIC LABORATORIES, INC.
K780871 06/14/1978 ARTERIAL LINE KIT ARGON MEDICAL CORP.
K780915 06/14/1978 780 SE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780916 06/14/1978 780 UE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780919 06/14/1978 M25 PP (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780920 06/14/1978 MM-CE 11 (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780921 06/14/1978 MM-CE DM (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780914 06/14/1978 PM 25 PP (BODY AID) ARGOSY INTL. (USA), INC.
K780917 06/14/1978 PRIMO CE (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780918 06/14/1978 PRIMO CEDM (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780922 06/14/1978 UM VII (BEHIND THE EAR) ARGOSY INTL. (USA), INC.
K780978 06/22/1978 SINGLE USE ACTIVE ELECTRODE HANDLE ASPEN LABORATORIES, INC.
K780976 06/22/1978 SINGLE USE BALL ELECTRODE ASPEN LABORATORIES, INC.
K780977 06/22/1978 SINGLE USE BLADE ELECTRODE ASPEN LABORATORIES, INC.
K780975 06/22/1978 SINGLE USE NEEDLE ELECTRODE ASPEN LABORATORIES, INC.
K781007 06/30/1978 AUTO-CON BARNES-HIND, INC.
K780903 06/28/1978 CLINICAL ANALYZER SYSTEM BAUSCH & LOMB, INC.
K780902 06/28/1978 FISHER SPECTROPHOTOMETER BAUSCH & LOMB, INC.
K780665 06/06/1978 RECAP BCA BIOLOGICAL CORP. OF AMERICA
K780858 06/22/1978 PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780787 06/06/1978 TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780913 06/22/1978 ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM BECKMAN INSTRUMENTS, INC.
K780554 06/06/1978 CLIN. CHEM. CONTROL SERUM-QUANTITATE BECKMAN INSTRUMENTS, INC.
K781041 06/28/1978 ELECTROENCEPHALOGRAPH ACCUTRACE 100 BECKMAN INSTRUMENTS, INC.
K781005 06/28/1978 ELECTROENCEPHALOGRAPH ACCUTRATE 200 BECKMAN INSTRUMENTS, INC.
K780847 06/13/1978 NINHYDRIN REAGENT KIT BECKMAN INSTRUMENTS, INC.
K780714 06/06/1978 PLATELET CONTROL BHP DIAGNOSTIX, INC.
K780761 06/30/1978 ELECTRO-PLETHYSMOGRAPH BIOTECX LABORATORIES, INC.
K780802 06/13/1978 ARMTROL AND FERMTROL BIOTRON LTD.
K780803 06/06/1978 TILL-U-TEST, DIP SLIDE BIOTRON LTD.
K780873 06/14/1978 THYMUNE-M BURROUGHS WELLCOME CO.
K780874 06/14/1978 THYMUNE-T BURROUGHS WELLCOME CO.
K780438 06/28/1978 SAFETY SPRING GUIDES, TEFLON COATED C.R. BARD, INC.
K780870 06/22/1978 RIA SYSTEM FOR HUMAN F-S HORMONE CALBIOCHEM-BEHRING CORP.
K780433 06/13/1978 FIBER OPTIC ADJUSTABLE HEADLIGHT CAMERON-MILLER, INC.
K780811 06/22/1978 DENTAL ABRASIVE DEVICE CAVITRON CORP.
K780982 06/22/1978 KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT CIS RADIOPHARMACEUTICALS, INC.
K780707 06/14/1978 T4-RIA KIT CLINICAL BIORESEARCH
K780653 06/14/1978 EXTRACORPEAL CARDIOTOMY BLOOD FILTER COBE LABORATORIES, INC.
K780569 06/14/1978 L-12, L-21, AND L-22 ELECTRODES CORATOMIC, INC.
K780453 06/30/1978 STANICOR THETA MODEL 221 CARDIAC PACER CORDIS CORP.
K780391 06/14/1978 PODIATRIC MATERIAL CROWN DELTA CORP.
K780801 06/13/1978 ISOZYME - ID CPK MARKER DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780724 06/02/1978 BUBBLE SUCTION TUBING DAVOL, INC.
K780833 06/14/1978 ESTIC MICROFILL DEGUSSA DENTAL, INC.
K780832 06/14/1978 ESTILUX MICROFILL DEGUSSA DENTAL, INC.
K780808 06/22/1978 PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) DENTAL VENTURES OF AMERICA, INC.
K780786 06/14/1978 DENTURE RELINE MATERIAL DENTSPLY INTL.
K780904 06/22/1978 KNEE, TOTAL, FEMORAL & TIBIAL DEPUY, INC.
K780773 06/22/1978 PROSTHESIS, HIP, CATHCART, SCHILLER MOD. DEPUY, INC.
K780289 06/14/1978 NERVE APPROXIMATER EDWARD WECK, INC.
K780780 06/30/1978 MICROPULSE 22S PACEMAKER EDWARDS PACEMAKER SYSTEMS
K780930 06/14/1978 5543 INDEPENDENT VIEWING SYSTEM EMI MEDICAL, INC.
K780995 06/22/1978 COMPUTERIZED AXIAL TOMOGRAPHY EMI MEDICAL, INC.
K780736 06/02/1978 CT 5221 DOSE REDUCING COLLIMATORS EMI MEDICAL, INC.
K780737 06/02/1978 CT BLANKETS (BOLUS MATERIAL) EMI MEDICAL, INC.
K780928 06/14/1978 CT5137 HIGH RESOLUTION OPTION EMI MEDICAL, INC.
K780948 06/22/1978 SYSTEM, PLANNING, TREATMENT EMI THERAPY SYSTEMS, INC.
K780681 06/14/1978 ARTERIOVENOUS BLOOD TUBING SETS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780682 06/22/1978 SINGLE PATIENT SYSTEMS EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K780994 06/30/1978 CERVICAL COLLAR FOX INSTRUMENTS, INC.
K780805 06/06/1978 S/D 600 SPHYGMOMANOMETER AND PULSEMETER G & W APPLIED SCIENCE LABORATORIES
K780855 06/02/1978 GAMMA CAMERA G.D. SEARLE AND CO.
K780471 06/02/1978 GASTRIC LAVAGE KIT GAYMAR INDUSTRIES, INC.
K780963 06/27/1978 X-RAY SYSTEM GENERAL X-RAY, INC.
K780907 06/22/1978 MIC-2000 GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
K780888 06/28/1978 THERMO SET ELECTRONIC TEM. CONTROLLER GILFORD INSTRUMENT LABORATORIES, INC.
K780798 06/13/1978 GOULD-STATHAM SP1405 PRESSURE MONITOR GOULD, INC.
K780797 06/13/1978 TRANSDUCER, PRESSURE, OPTION, H-P, P23ID GOULD, INC.
K780999 06/27/1978 X-RAY FRAME HOLDER GREAT EASTERN LUMBER CO., INC.
K780830 06/14/1978 ISOTONIC BUFFERED SALINE HARLECO
K780829 06/22/1978 SYSING AND HEMOGLOBIN REAGENT HARLECO
K780936 06/22/1978 PHONIC EAR HC ELECTRONICS
K780807 06/02/1978 HBF-QUIPLATE METHODOLOGY HELENA LABORATORIES
K780782 06/14/1978 M. 1336S CATHODE-RAY TUBE DISPLAY HEWLETT-PACKARD CO.
K780812 06/13/1978 ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 HONEYWELL, INC.
K780890 06/13/1978 CAPP TERMINAL DEVICE HOSMER DORRANCE CORP.
K780892 06/13/1978 FRACTURE BRACING HOSMER DORRANCE CORP.
K780891 06/13/1978 POST-OPERATIVE HIP ORTHOSIS HOSMER DORRANCE CORP.
K780582 06/22/1978 DETECTOR, BUBBLE & FOAM HOSPAL MEDICAL CORP.
K780857 06/13/1978 MIXING BOWL & SPATULA, DISPOSABLE HOWMEDICA CORP.
K780834 06/02/1978 PREVI DENT PROPHYLAXIS MINT NDC HOYT LABORATORIES
K780445 06/19/1978 LIQUID CRYSTAL DISPLAY DIGITAL WATCH HUGHES AIRCRAFT CO.
K780452 06/21/1978 THERA-PAK HYDRO-MED PRODUCTS, INC.
K780804 06/14/1978 HYGIENIC ANCHORINGS HYGIENIC DENTAL MFG., CO., THE
K780785 06/14/1978 DILUTOR TRANSPORTER HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780753 06/06/1978 LAS-R HUMAN IGE TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780882 06/28/1978 DILUTER/DISPENSER INNOVATIVE MEDICAL SYSTEMS, INC.
K780789 06/13/1978 PERALISTIC PUMP MODEL 2000 INNOVATIVE MEDICAL SYSTEMS, INC.
K780790 06/22/1978 IDI 200 GAMMA COUNTER ISO-DATA, INC.
K780813 06/28/1978 IDI GDR DATA REDUCTION SYSTEM ISO-DATA, INC.
K780783 06/06/1978 AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT J.T. BAKER CHEMICAL CO.
K780924 06/22/1978 ELECTROSURGICAL GROUNDING PAD CABLE JOHNSON & JOHNSON PROFESSIONALS, INC.
K780718 06/28/1978 SOF-WICKLAP PAD JOHNSON & JOHNSON PROFESSIONALS, INC.
K780823 06/30/1978 CONTACT LENS CLEANSER KETCHUM LABORATORIES, INC.
K780846 06/19/1978 DRAPING MATERIAL, COLBALT 60 STERILE KIMBERLY-CLARK CORP.
K780954 06/22/1978 SCISSORS, HOOK, ELECTROSURGICAL KLI
K780955 06/22/1978 SCISSORS, HOOK, ELECTROSURGICAL KLI
K780559 06/06/1978 DISPOSABLE INFUSION SET KS MEDICAL SUPPLY CO.
K780967 06/22/1978 LEE-ALLOY LEE PHARMACEUTICALS
K780965 06/22/1978 NEW RESTODENT LEE PHARMACEUTICALS
K781018 06/30/1978 DX TOOTHBRUSH LEVER BROTHERS COMPANY, INC.
K780537 06/02/1978 EAR ELECTRODE-ADULT & PEDIATRIC LIFE-TECH INSTRUMENTS, INC.
K780539 06/22/1978 STIMULATOR MODEL 8021 LIFE-TECH INSTRUMENTS, INC.
K780925 06/22/1978 EB-VCA, TEST, ANTIBODY, FLUORESCENT LITTON BIONETICS
K781044 06/30/1978 ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM LITTON DENTAL PRODUCTS
K780460 06/28/1978 DENTAL AIR BRUSH M. JOEL GEBHART, D.D.S.
K780969 06/27/1978 GAMMA CAMERA MACHLETT LABORATORIES, INC.
K780659 06/13/1978 HDL CHOLESTEROL MACOMB CHEMICAL CO.
K780447 06/22/1978 URIC ACID REFERENCE SERA MACOMB CHEMICAL CO.
K781008 06/28/1978 ISOTONIC DILUENT MALLINCKRODT CRITICAL CARE
K780956 06/22/1978 OTOLOGICAL VENTILATION TUBES MCGHAN MEDICAL CORP.
K780810 06/14/1978 MLA ELECTRA 750 COAGULATION TIMER MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
K780800 06/06/1978 ELECTRONIC THERMOMETER METEK CORP.
K780393 06/19/1978 BIOSTATOR GLUCOSE ANALYZER MILES LABORATORIES, INC.
K780352 06/28/1978 IMMUNOZYME TOXOPLASMA ANTIBODY MILLIPORE CORP.
K780814 06/30/1978 SAFETY STOP NECKSTRAP NORTHWEST ORTHODONTICS, INC.
K780662 06/06/1978 SUPPLEMENTAL TYGON PAC-MONITORING LINES NORTON PERFORMANCE PLASTICS CORP.
K780679 06/14/1978 B-HCG-RIA NUCLEAR MEDICAL SYSTEMS, INC.
K780468 06/19/1978 CLINICAL GRAPHICS ANALYZER NUMONICS CORP.
K780901 06/28/1978 AUTOMATED ELECTROPHORESIS SYSTEM OLYMPUS CORP.
K781001 06/30/1978 CHAIRS WITH CASTORS ORTHOPEDIC EQUIPMENT CO., INC.
K780935 06/19/1978 GRAB BAR ORTHOPEDIC EQUIPMENT CO., INC.
K780684 06/06/1978 PATIENT LIFT ORTHOPEDIC EQUIPMENT CO., INC.
K780564 06/30/1978 FECATEST OTTO C. WATZKA
K780912 06/28/1978 ADJUSTABLE DISPENSOR OXFORD LABORATORIES, INC.
K780887 06/22/1978 IMPROVED DISPOSABLE HYPODERMIC NEEDLE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781033 06/28/1978 HEARING AID PHONEMICS, INC.
K780827 06/13/1978 URIC ACID RAPID STAT KIT PIERCE CHEMICAL CO.
K781035 06/30/1978 PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX PREMIER DENTAL PRODUCTS CO.
K781034 06/30/1978 PREMIER INLAY PLACER PREMIER DENTAL PRODUCTS CO.
K780796 06/22/1978 ZYTRON PREMIER DENTAL PRODUCTS CO.
K780818 06/22/1978 LAPAROTOMY SPONGE QUALTEX, INC.
K780671 06/06/1978 125 I-T3 UPTAKE REAGENT RADIOIMMUNOASSAY, INC.
K780672 06/06/1978 125 I-T4 RIA REAGENT RADIOIMMUNOASSAY, INC.
K780735 06/13/1978 URINARY CATHETER CARE SET SHIELD LABORATORIES, INC.
K780788 06/22/1978 IRRIGATION CATHETER SHILEY, INC.
K780931 06/28/1978 SOFT LENS INSERTER SOFT-SERT
K780465 06/02/1978 VOLUME CONTROL DEVICE VCD-150 SORENSEN RESEARCH
K780258 06/13/1978 MILK BATH CONCENTRATE SPARTA INSTRUMENT CORP.
K780757 06/06/1978 KRYORACK/4 STRECK LABORATORIES, INC.
K780769 06/02/1978 S-100 CT SCANNER SYNTEX CORP.
K780881 06/22/1978 EMIT CLINICAL PROCESSOR - CP 5000 SYVA CO.
K780716 06/14/1978 TECHNICON BGII ANALYZER TECHNICON INSTRUMENTS CORP.
K780764 06/06/1978 NON-STERILE FOLDED GAUZE THE OWENBY CO.
K780792 06/13/1978 TESTOSTERONE RADIOIMMUNOASSAY KIT 125I THE UPJOHN CO.
K780909 06/28/1978 SYSMEX AUTO. BLOOD CELL COUNTER, CC-120 TOA MEDICAL ELECTRONICS USA, INC.
K780911 06/28/1978 SYSMEX PLATELET COUNTER, PL-110 TOA MEDICAL ELECTRONICS USA, INC.
K780910 06/28/1978 SYSTEM AUTO. BLOOD CELL COUNTER CC-110 TOA MEDICAL ELECTRONICS USA, INC.
K780619 06/28/1978 PREFORMED TOOTH POSITIONER TP LABORATORIES, INC.
K780354 06/14/1978 CRYOCYTE PACK TRAVENOL LABORATORIES, S.A.
K780668 06/13/1978 SOLUTIONS FOR RESPIRATORY THERAPY TRAVENOL LABORATORIES, S.A.
K780898 06/30/1978 INSTANT CURE-1 ULTRA-LIGHT CORP.
K780947 06/22/1978 510 BEDSIDE X-RAY SYSTEM UNION CARBIDE CORP.
K780725 06/06/1978 CENTRIA CORTISOL RIA UNION CARBIDE CORP.
K780695 06/22/1978 AUTO SUTURE DISPOSABLE STAPLING INSTRU. UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K780851 06/30/1978 CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC VARIAN ASSOC., INC.
K780864 06/14/1978 DIAMOND STONES VENTURE TECHNOLOGY, INC.
K780717 06/30/1978 EXTERNAL TEST PULSE GENERATOR VITATRON MEDICAL BV
K780734 06/22/1978 ANTICONVULSANTS II CALIBRATOR KIT VITEK SYSTEMS, INC.
K780733 06/22/1978 ANTICONVULSANTS III CALIBRATOR KIT VITEK SYSTEMS, INC.
K780628 06/06/1978 HALOGEN EXAM. LITE #48400 WELCH ALLYN, INC.
K781029 06/28/1978 OTOSCOPE, DIAG. MODELS 20100 & 20200 WELCH ALLYN, INC.
K781049 06/29/1978 ACU-TEST IN-HOME PREGNANCY TEST WILLIAMS, THE J.B. CO., INC.
K780929 06/30/1978 COTTON TIPPED POINT YOUNG DENTAL MANUFACTURING CO 1, LLC.


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