FDA 510(k) Decisions During July, 1978  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K781145 07/27/1978 MONITOR KITS, BLOOD LEVEL 3M HEALTH CARE, SARNS
K780565 07/07/1978 SUTURELESS SKIN CLOSURE ABBOTT LABORATORIES
K780878 07/31/1978 LEG BAG ABCO DEALERS, INC.
K780879 07/31/1978 URETHRO CATHETERIZATION TRAY ABCO DEALERS, INC.
K780957 07/06/1978 SET, ADMINISTRATION, MANUAL, DIALYSIS AMERICAN MEDICAL PRODUCTS, INC.
K781095 07/17/1978 HEARING AID, BEHIND THE EAR ARGOSY INTL. (USA), INC.
K781094 07/17/1978 HEARING AID, EYEGLASS ARGOSY INTL. (USA), INC.
K781096 07/17/1978 HEARING AID, EYEGLASS, B-12 ARGOSY INTL. (USA), INC.
K781080 07/07/1978 GALVANATOR, MODEL 770 AVRA CORP.
K780939 07/17/1978 BARD-PARKER ARTERIAL MONITORING SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780859 07/27/1978 PRINCETON BIOMEDIX URICASE (UV) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780980 07/27/1978 PLATELET CONTROL BHP DIAGNOSTIX, INC.
K781091 07/17/1978 KNEE INSTRUMENTATION, CONDYLAR BIOMET, INC.
K780849 07/31/1978 DENTROL LIQUID DENTURE ADHESIVE BLOCK DRUG COMPANY, INC.
K780964 07/27/1978 TRANSPORT INCUBATOR CAVITRON CORP.
K781040 07/18/1978 CT SCANNER ND 8000 CGR MEDICAL CORP.
K780854 07/27/1978 IN VITRO NEONATAL T4 CLINICAL ASSAYS, INC.
K781013 07/28/1978 ENZYMATIC REAGENT FOR CHOLESTEROL MEAS COULTER ELECTRONICS, INC.
K781321 07/31/1978 TENS-O-TEST CUROMATIC, INC.
K781077 07/27/1978 CONTROL, HEMATOLOGY, CH-60 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K781012 07/27/1978 RIA TEST KIT SYS. DAMON KIQUISOL FREE DAMON CORP.
K781165 07/27/1978 CHOLESTEROL & HDL CHOL. PROCEDURE DATA MEDICAL ASSOCIATES, INC.
K781150 07/27/1978 RIA TSH IN HUMAN SERUM OR PLASMA DIAGNOSTIC CORP. OF AMERICA
K780766 07/27/1978 (125 I) DIGITOXIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K780750 07/27/1978 O2 CONNECTOR DIEMOLDING CORP.
K780484 07/17/1978 SILASTIC BRAND PENILE IMPLANT DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS
K780944 07/27/1978 LIQUID CHROMATOGRAPH MODEL 850 E.I. DUPONT DE NEMOURS & CO., INC.
K780945 07/27/1978 LIQUID CHROMATOGRAPH MODEL 860 E.I. DUPONT DE NEMOURS & CO., INC.
K780933 07/27/1978 PREP I AUTOMATED SAMPLE PROCESSOR E.I. DUPONT DE NEMOURS & CO., INC.
K781042 07/27/1978 PROLITH 23S PACEMAKER EDWARDS PACEMAKER SYSTEMS
K781051 07/17/1978 EMISONIC 4201 EMI MEDICAL, INC.
K781084 07/18/1978 THERAPAX 150A EMI THERAPY SYSTEMS, INC.
K781009 07/27/1978 ANALYZER, SERUM IRON & TOTAL IRON BINDIN ENVIRONMENTAL SCIENCES ASSOC., INC.
K781195 07/31/1978 BAG, WALDER FRED SAMMONS, INC.
K781194 07/31/1978 BAG, WHEELCHAIR FRED SAMMONS, INC.
K781198 07/31/1978 BOARD, SCOOTER FRED SAMMONS, INC.
K781201 07/31/1978 BOARD, TRANSFER, FENDER FRED SAMMONS, INC.
K781204 07/31/1978 BOOK HOLDER FRED SAMMONS, INC.
K781206 07/31/1978 FOOT POSITIONER FRED SAMMONS, INC.
K781199 07/31/1978 HOLDER, CARD, QUAD-QUIP FRED SAMMONS, INC.
K781193 07/31/1978 KNIFE, LARGE HANDLE FRED SAMMONS, INC.
K781192 07/31/1978 KNIFE, ROCKER, SLOTTED HANDLE FRED SAMMONS, INC.
K781200 07/31/1978 NAIL CLIPPERS, ONE-HANDED FRED SAMMONS, INC.
K781191 07/31/1978 SPORKS, PLASTIC, DISP. FRED SAMMONS, INC.
K781197 07/31/1978 STICK, UTILITY FRED SAMMONS, INC.
K781205 07/31/1978 TOILET AID FRED SAMMONS, INC.
K781203 07/31/1978 TRAY, LAP, MOLDED FRED SAMMONS, INC.
K781196 07/31/1978 UTENSILS, WEIGHTED FRED SAMMONS, INC.
K781202 07/31/1978 VEST, SUPPORT, TRUNK FRED SAMMONS, INC.
K780700 07/17/1978 LUNDIA PLATE DISPOSABLE DIALYZER GAMBRO, INC.
K781030 07/17/1978 X-RAY UNIT, PORTABLE GX-101 AEC GENERAL X-RAY, INC.
K780708 07/17/1978 AUTOMATIC RETRACTOR HOLDER GREAT EASTERN LUMBER CO., INC.
K780738 07/17/1978 PENTAX ST-1A HAL-HEN CO., INC.
K781055 07/17/1978 FACE TENTS HOSPITAK, INC.
K781045 07/27/1978 A-33 DENTAL ALLOY HOWMEDICA CORP.
K781004 07/27/1978 HMA URIC ACID TEST HYCEL, INC.
K780946 07/27/1978 ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER HYCEL, INC.
K780962 07/27/1978 AUTOMATED ENZYME HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K781220 07/27/1978 ANTI-HUMAN LAMBDA SERUM ICL SCIENTIFIC
K781028 07/27/1978 KAPPA SERUM (FREE & BOUND) ANTI-HUMAN ICL SCIENTIFIC
K781027 07/27/1978 KAPPA SERUM (FREE) ANTI-HUMAN ICL SCIENTIFIC
K781025 07/27/1978 LAMBDA SERUM (FREE) ANTI-HUMAN ICL SCIENTIFIC
K781054 07/27/1978 LIFELINE AMBULATORY IMC
K780837 07/27/1978 URINARY DRAINAGE BAG INTERMED, INC.
K780998 07/27/1978 SCALPEL ISOLAB, INC.
K781089 07/17/1978 ONE INCISION BI-POLAR ELECTRO. FORCEPS KLI
K780574 07/17/1978 SUTURE CUTTER LASCHAL INSTRUMENT CORP.
K780585 07/19/1978 SURGICAL LASER LASER INDUSTRIES LTD.
K781107 07/17/1978 DISPENSER, GAS XENON MALLINCKRODT CRITICAL CARE
K780941 07/27/1978 CONDUCTIVE CUSHION MARKHAM SERVICE CO., INC.
K780715 07/17/1978 ANEROID TYPE BLOOD PRESSURE KIT MARS METAL CO., LTD.
K780831 07/27/1978 URINARY CATHETERIZATION SYSTEM W/O FOLEY MEDICAL DEVICES, INC.
K781218 07/27/1978 ANEMOMETER, NASAL, EXETER MEDIKA CORP.
K780622 07/28/1978 BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 MEDTRONIC VASCULAR
K780623 07/28/1978 ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 MEDTRONIC VASCULAR
K780809 07/28/1978 GENERATOR, PULSE MODELS 5920/5921 MEDTRONIC VASCULAR
K780741 07/28/1978 GENERATOR, PULSE, DEMAND, MODEL 5996 MEDTRONIC VASCULAR
K780621 07/26/1978 LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED MEDTRONIC VASCULAR
K780561 07/27/1978 VENTRICULAR INHIBITED PULSE GENERATOR MEDTRONIC VASCULAR
K780838 07/17/1978 PERCI MICRO TRONICS CORP.
K780310 07/31/1978 DERMATRON IONTOPHORESIS DEVICE MOTION CONTROL, INC.
K780660 07/28/1978 NITE TRAIN'R NITE TRAIN-R ENTERPRISES, INC.
K780985 07/27/1978 PVC LINES FOR MONITORING NORTON PERFORMANCE PLASTICS CORP.
K780984 07/17/1978 PVC QUICK PRIME LINES NORTON PERFORMANCE PLASTICS CORP.
K781079 07/17/1978 SONOGRAF ULTRASOUND B-SCANNING SYSTEM OHIO NUCLEAR, INC.
K780774 07/27/1978 PAPILLOTOMY KNIVES OLYMPUS CORP.
K780703 07/17/1978 CUFF PACER OMP LABORATORIES, INC.
K781082 07/07/1978 CAST BLOCK ORTHOPEDIC EQUIPMENT CO., INC.
K781112 07/17/1978 CAST WEDGE, YANCEY ORTHOPEDIC EQUIPMENT CO., INC.
K781031 07/27/1978 AEROPLAST DRESSING PARKE-DAVIS CO.
K780973 07/27/1978 SIGNAPAD PARKER LABORATORIES, INC.
K781085 07/17/1978 ASSURE NATURAL FIT TAMPON PERSONAL PRODUCTS CO.
K780900 07/17/1978 SLICK SET POLAMEDCO, INC.
K780781 07/27/1978 STILITH CARDIAC PACEMAKERS-M. 60 & 120 R.E. BROWN CO., INC.
K781101 07/17/1978 ELECTROSURGICAL UNIT 75 RITTER CO.
K780943 07/27/1978 BUN TEST UNI-UV BLOOD UREA NITROGEN TEST SCLAVO, INC.
K780986 07/18/1978 DIGITAL BLOOD PRESSURE MONITOR SEARS, ROEBUCK & CO.
K781223 07/27/1978 OXYGENATOR, BLOOD, INFANT/PEDIATRIC SHILEY, INC.
K780742 07/27/1978 INTRAORAL DENTAL X-RAY GENERATOR SIEMENS CORP.
K780983 07/27/1978 CALCIUM REAGENT SYSTEM NO. 585 SIGMA CHEMICAL CO.
K780817 07/27/1978 GLOBIN-TERGE SIMMLER & SON, INC.
K780658 07/19/1978 STERILE BLOOD ADMINISTRATION SET SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780657 07/19/1978 STERILE BLOOD COLLECTION SET SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780656 07/19/1978 STERILE INFUSION SET TYPE J SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780655 07/19/1978 STERILE INFUSION SET TYPE S SURU CHEMICALS & PHARMACEUTICALS, LTD.
K780997 07/27/1978 AMALGAM ALLOY SYNTEX CORP.
K781068 07/17/1978 AUTOMATIC FILM PROCESSORIO M. R80 TECNOMED, INC.
K781065 07/17/1978 PLURIMAT;RADIOGRAPHIC TUBE MOUNT TECNOMED, INC.
K781067 07/17/1978 PLURIX B; RADIOGRAPHIC TABLE TECNOMED, INC.
K781066 07/17/1978 PLURIX C; RADIOGRAPHIC TABLE TECNOMED, INC.
K780420 07/27/1978 GENERATOR, PULSE, CARDIAC, IMPLANTABLE TELECTRONICS, INC.
K780421 07/07/1978 GENERATOR, PULSE, CARDIAC, IMPLANTABLE TELECTRONICS, INC.
K781179 07/27/1978 WRENCH, GEXAGON, DRIVER TELECTRONICS, INC.
K781020 07/27/1978 (AST) OR (ALT) UV DETERM. PHY. PHOS. THE DOW CHEMICAL CO.
K781213 07/27/1978 COMPRESSOR, AIR, MINI-SILENT THE JOHN BUNN CO.
K780652 07/27/1978 HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 THE LONDON CO.
K781010 07/27/1978 MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS THE PERKIN-ELMER CORP.
K780970 07/27/1978 BURETTE SET WITH AIR CONTROL LEVER TRAVENOL LABORATORIES, S.A.
K780794 07/27/1978 IRRIGATION CAP TRAVENOL LABORATORIES, S.A.
K780974 07/27/1978 BACILLUS PUMILUS UROL, INC.
K780765 07/17/1978 PERCUTANEOUS SURAPUBIC CATHETER VANCE PRODUCTS, INC.
K781057 07/17/1978 CLINAC 20 (OPTIONAL 18 MV VERSION) VARIAN ASSOC., INC.
K780455 07/27/1978 QUANTITATIVE DETERMINATION OF PORPHYRINS WHALE SCIENTIFIC, INC.


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