FDA 510(k) Applications Received During May, 1978

FDA 510(k) Number Submission Date Device Name Applicant Contact
K780880 05/30/1978 Y-TYPE BLOOD SET ABBOTT LABORATORIES
K780877 05/30/1978 ENEMA BAG ABCO DEALERS, INC.
K780795 05/15/1978 GAUZE SPONGES ABCO DEALERS, INC.
K780806 05/10/1978 LAPOROTOMY SPONGE ABCO DEALERS, INC.
K780878 05/30/1978 LEG BAG ABCO DEALERS, INC.
K780723 05/02/1978 OTOSCOPE SPECULA ABCO DEALERS, INC.
K780879 05/30/1978 URETHRO CATHETERIZATION TRAY ABCO DEALERS, INC.
K780853 05/22/1978 OP-SITE ADHESIVE DRAPES ACME UNITED CORP.
K780722 05/01/1978 ADVANCED DENTURE SYSTEM ADVANCED MARKETING RESEARCH CO.
K780876 05/30/1978 ULTRASONIC IMAGER AIR-SHIELDS, INC.
K780791 05/15/1978 SGPT/ALT REAGENT SYSTEM AMERICAN MONITOR CORP.
K780726 05/03/1978 TSH RIA KIT AMERSHAM CORP.
K780799 05/15/1978 VITAMIN B12 RADIOASSAY AMERSHAM CORP.
K780771 05/05/1978 MICRO RASPS AMSCO CO.
K780759 05/08/1978 MODEL 902 STAND APPLIED MEDICAL RESEARCH
K780754 05/09/1978 NEONATAL MONITOR APPLIED MEDICAL RESEARCH
K780835 05/23/1978 ARANTROL ARANCO DIAGNOSTIC LABORATORIES, INC.
K780776 05/08/1978 ARCOBIOLITH PACEMAKER MODEL ARCO MEDICAL PRODUCTS CO.
K780871 05/30/1978 ARTERIAL LINE KIT ARGON MEDICAL CORP.
K780903 05/31/1978 CLINICAL ANALYZER SYSTEM BAUSCH & LOMB, INC.
K780902 05/31/1978 FISHER SPECTROPHOTOMETER BAUSCH & LOMB, INC.
K780858 05/24/1978 PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780859 05/24/1978 PRINCETON BIOMEDIX URICASE (UV) BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780787 05/12/1978 TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K780847 05/23/1978 NINHYDRIN REAGENT KIT BECKMAN INSTRUMENTS, INC.
K780886 05/26/1978 SYSTEM 6000 AUTOMATED RIA ANALYZER BECKMAN INSTRUMENTS, INC.
K780721 05/01/1978 IDENTI-CLAMPS BERKELEY BIO-MEDICAL, INC.
K780720 05/01/1978 IDENTI-LOOPS BERKELEY BIO-MEDICAL, INC.
K780828 05/19/1978 NURITE II BIO-MEDICAL SYSTEMS CORP.
K780869 05/30/1978 CELL CULTURE LINES BIOASSAY SYSTEMS RESEARCH CORP.
K780848 05/23/1978 PORTABLE CLOSED WOUND SUCTION EVACUATOR BIOMET, INC.
K780761 05/09/1978 ELECTRO-PLETHYSMOGRAPH BIOTECX LABORATORIES, INC.
K780802 05/11/1978 ARMTROL AND FERMTROL BIOTRON LTD.
K780803 05/11/1978 TILL-U-TEST, DIP SLIDE BIOTRON LTD.
K780755 05/08/1978 SHORTWAVE DIATHERMY MODEL 802 BIRTCHER CORP.
K780849 05/23/1978 DENTROL LIQUID DENTURE ADHESIVE BLOCK DRUG COMPANY, INC.
K780873 05/30/1978 THYMUNE-M BURROUGHS WELLCOME CO.
K780874 05/30/1978 THYMUNE-T BURROUGHS WELLCOME CO.
K780870 05/30/1978 RIA SYSTEM FOR HUMAN F-S HORMONE CALBIOCHEM-BEHRING CORP.
K780811 05/18/1978 DENTAL ABRASIVE DEVICE CAVITRON CORP.
K780854 05/22/1978 IN VITRO NEONATAL T4 CLINICAL ASSAYS, INC.
K780719 05/01/1978 FUNGUS FIGHTER INSOLES COMBE, INC.
K780872 05/30/1978 CYTOLOGY BRUSH COOPERVISION, INC.
K780885 05/26/1978 CORDIA R CORDIS CORP.
K780778 05/11/1978 RTV SILICONE HAND KNEADABLE PUTTY CROWN DELTA CORP.
K780801 05/11/1978 ISOZYME - ID CPK MARKER DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K780724 05/03/1978 BUBBLE SUCTION TUBING DAVOL, INC.
K780833 05/22/1978 ESTIC MICROFILL DEGUSSA DENTAL, INC.
K780832 05/22/1978 ESTILUX MICROFILL DEGUSSA DENTAL, INC.
K780808 05/18/1978 PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) DENTAL VENTURES OF AMERICA, INC.
K780786 05/12/1978 DENTURE RELINE MATERIAL DENTSPLY INTL.
K780904 05/30/1978 KNEE, TOTAL, FEMORAL & TIBIAL DEPUY, INC.
K780773 05/04/1978 PROSTHESIS, HIP, CATHCART, SCHILLER MOD. DEPUY, INC.
K780868 05/30/1978 CHEST ROLLS DEVON INDUSTRIES, INC.
K780866 05/30/1978 CHEST ROLLS HOLDER DEVON INDUSTRIES, INC.
K780865 05/30/1978 MAGNETIC DRAPE - INSTRUMENT HOLDER DEVON INDUSTRIES, INC.
K780867 05/30/1978 PAD HOLDER KIT DEVON INDUSTRIES, INC.
K780766 05/05/1978 (125 I) DIGITOXIN RIA KIT DIAGNOSTIC PRODUCTS CORP.
K780750 05/08/1978 O2 CONNECTOR DIEMOLDING CORP.
K780780 05/11/1978 MICROPULSE 22S PACEMAKER EDWARDS PACEMAKER SYSTEMS
K780736 05/01/1978 CT 5221 DOSE REDUCING COLLIMATORS EMI MEDICAL, INC.
K780737 05/01/1978 CT BLANKETS (BOLUS MATERIAL) EMI MEDICAL, INC.
K780819 05/17/1978 GLYCOHEMOGLOBIN-SKREEN TEST KIT EPPENDORF-BRINKMANN, INC.
K780784 05/12/1978 ASPIRATION NEEDLE FERRIS MFG. CORP.
K780805 05/11/1978 S/D 600 SPHYGMOMANOMETER AND PULSEMETER G & W APPLIED SCIENCE LABORATORIES
K780855 05/19/1978 GAMMA CAMERA G.D. SEARLE AND CO.
K780888 05/26/1978 THERMO SET ELECTRONIC TEM. CONTROLLER GILFORD INSTRUMENT LABORATORIES, INC.
K780894 05/26/1978 AIRFLOMETER GLAXO AUSTRALIA PLY. LTD.
K780798 05/15/1978 GOULD-STATHAM SP1405 PRESSURE MONITOR GOULD, INC.
K780797 05/15/1978 TRANSDUCER, PRESSURE, OPTION, H-P, P23ID GOULD, INC.
K780738 05/02/1978 PENTAX ST-1A HAL-HEN CO., INC.
K780883 05/30/1978 E-Z-JECTOR HARCO PRODUCTS
K780884 05/30/1978 HYPO-GRIP HARCO PRODUCTS
K780830 05/19/1978 ISOTONIC BUFFERED SALINE HARLECO
K780829 05/19/1978 SYSING AND HEMOGLOBIN REAGENT HARLECO
K780807 05/04/1978 HBF-QUIPLATE METHODOLOGY HELENA LABORATORIES
K780782 05/12/1978 M. 1336S CATHODE-RAY TUBE DISPLAY HEWLETT-PACKARD CO.
K780768 05/05/1978 MODEL 5621A INTERFACE HEWLETT-PACKARD CO.
K780812 05/17/1978 ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330 HONEYWELL, INC.
K780890 05/31/1978 CAPP TERMINAL DEVICE HOSMER DORRANCE CORP.
K780892 05/31/1978 FRACTURE BRACING HOSMER DORRANCE CORP.
K780891 05/31/1978 POST-OPERATIVE HIP ORTHOSIS HOSMER DORRANCE CORP.
K780857 05/24/1978 MIXING BOWL & SPATULA, DISPOSABLE HOWMEDICA CORP.
K780834 05/24/1978 PREVI DENT PROPHYLAXIS MINT NDC HOYT LABORATORIES
K780804 05/11/1978 HYGIENIC ANCHORINGS HYGIENIC DENTAL MFG., CO., THE
K780785 05/12/1978 DILUTOR TRANSPORTER HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780729 05/02/1978 LAS-R HUMAN COMPLEMENT CLQ TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780753 05/08/1978 LAS-R HUMAN IGE TEST HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES
K780882 05/30/1978 DILUTER/DISPENSER INNOVATIVE MEDICAL SYSTEMS, INC.
K780789 05/15/1978 PERALISTIC PUMP MODEL 2000 INNOVATIVE MEDICAL SYSTEMS, INC.
K780820 05/19/1978 HEARING AID MODEL 8148 INT'L HEARING AIDS, INC.
K780821 05/19/1978 HEARING AID MODEL 8160H INT'L HEARING AIDS, INC.
K780822 05/19/1978 HEARING AID MODEL 8160U INT'L HEARING AIDS, INC.
K780837 05/23/1978 URINARY DRAINAGE BAG INTERMED, INC.
K780790 05/15/1978 IDI 200 GAMMA COUNTER ISO-DATA, INC.
K780813 05/15/1978 IDI GDR DATA REDUCTION SYSTEM ISO-DATA, INC.
K780783 05/12/1978 AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT J.T. BAKER CHEMICAL CO.
K780730 05/02/1978 FIGURETRIM JAY-MAR INTERNATIONAL ENTERPRISES, IN
K780779 05/11/1978 ECONO-FLOAT WATER FLOTATION MATTRESS JEFFERSON INDUSTRIES, INC.
K780896 05/30/1978 NEEDLES, DESIGN CHANGE, IV CATHETERS JELCO LABORATORIES
K780718 05/01/1978 SOF-WICKLAP PAD JOHNSON & JOHNSON PROFESSIONALS, INC.
K780823 05/22/1978 CONTACT LENS CLEANSER KETCHUM LABORATORIES, INC.
K780846 05/24/1978 DRAPING MATERIAL, COLBALT 60 STERILE KIMBERLY-CLARK CORP.
K780831 05/22/1978 URINARY CATHETERIZATION SYSTEM W/O FOLEY MEDICAL DEVICES, INC.
K780810 05/18/1978 MLA ELECTRA 750 COAGULATION TIMER MEDICAL LABORATORY AUTOMATION SYSTEMS, INC.
K780809 05/18/1978 GENERATOR, PULSE MODELS 5920/5921 MEDTRONIC VASCULAR
K780741 05/01/1978 GENERATOR, PULSE, DEMAND, MODEL 5996 MEDTRONIC VASCULAR
K780758 05/08/1978 NEUROLOGICAL SCREENING STIMULATOR M 3623 MEDTRONIC VASCULAR
K780800 05/15/1978 ELECTRONIC THERMOMETER METEK CORP.
K780838 05/22/1978 PERCI MICRO TRONICS CORP.
K780814 05/18/1978 SAFETY STOP NECKSTRAP NORTHWEST ORTHODONTICS, INC.
K780747 05/08/1978 SNAP-WAY NORTHWEST ORTHODONTICS, INC.
K780774 05/03/1978 PAPILLOTOMY KNIVES OLYMPUS CORP.
K780763 05/08/1978 ENTRAX TRACTION UNIT ORTHOPEDIC EQUIPMENT CO., INC.
K780889 05/31/1978 DIGOXIN STANDARDS IN HUMAN SERUM PCL-RIA, INC.
K780887 05/26/1978 IMPROVED DISPOSABLE HYPODERMIC NEEDLE PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K780826 05/19/1978 BILIRUBIN RAPID STAT KIT PIERCE CHEMICAL CO.
K780825 05/19/1978 TRIGLYCERIDE C-37 RAPID STAT KIT PIERCE CHEMICAL CO.
K780827 05/19/1978 URIC ACID RAPID STAT KIT PIERCE CHEMICAL CO.
K780900 05/15/1978 SLICK SET POLAMEDCO, INC.
K780796 05/15/1978 ZYTRON PREMIER DENTAL PRODUCTS CO.
K780818 05/17/1978 LAPAROTOMY SPONGE QUALTEX, INC.
K780781 05/12/1978 STILITH CARDIAC PACEMAKERS-M. 60 & 120 R.E. BROWN CO., INC.
K780845 05/23/1978 CONCHANEOPAK A CARTRIDGE HUMIDIFIER RESPIRATORY CARE, INC.
K780775 05/04/1978 MEDICAL PROTEIN HYDROLYSATE "REVITAL" ROBERTSON RESOURCES, INC.
K780735 05/01/1978 URINARY CATHETER CARE SET SHIELD LABORATORIES, INC.
K780772 05/04/1978 BJORK-SHILEY CARDIAC HEART VALVE SHILEY, INC.
K780762 05/08/1978 EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE SHILEY, INC.
K780788 05/15/1978 IRRIGATION CATHETER SHILEY, INC.
K780742 05/01/1978 INTRAORAL DENTAL X-RAY GENERATOR SIEMENS CORP.
K780817 05/18/1978 GLOBIN-TERGE SIMMLER & SON, INC.
K780757 05/08/1978 KRYORACK/4 STRECK LABORATORIES, INC.
K780843 05/22/1978 BARRIER ABDOMINAL PACK FABRIC 450 SURGIKOS, INC.
K780842 05/22/1978 BARRIER BASIC PACK FABRIC 450 SURGIKOS, INC.
K780856 05/24/1978 BARRIER GYNECOLOGY PACK FABRIC 450 SURGIKOS, INC.
K780840 05/23/1978 BARRIER LAPAROTOMY SHEET 450 SURGIKOS, INC.
K780841 05/23/1978 BARRIER MEDIUM SHEET 450 SURGIKOS, INC.
K780844 05/22/1978 BARRIER OBSTETRICAL PACK FABRIC 450 SURGIKOS, INC.
K780839 05/23/1978 BARRIER PEDIATRIC/INCISE DRAPE 450 SURGIKOS, INC.
K780769 05/05/1978 S-100 CT SCANNER SYNTEX CORP.
K780881 05/30/1978 EMIT CLINICAL PROCESSOR - CP 5000 SYVA CO.
K780777 05/04/1978 BAGS, PLASTIC, STERILE FOR GENERATORS TELECTRONICS, INC.
K780862 05/30/1978 MODEL 290 OXYGEN RICH AIR SUPPLY UNIT THE JOHN BUNN CO.
K780863 05/30/1978 MODEL 65 HIGH & LOW PRESSURE ALARM THE JOHN BUNN CO.
K780764 05/04/1978 NON-STERILE FOLDED GAUZE THE OWENBY CO.
K780792 05/15/1978 TESTOSTERONE RADIOIMMUNOASSAY KIT 125I THE UPJOHN CO.
K780749 05/04/1978 SPEECH AUDIOMETER RA 226 TRACOR INSTRUMENTS, INC.
K780794 05/15/1978 IRRIGATION CAP TRAVENOL LABORATORIES, S.A.
K780861 05/31/1978 ELECTRONIC CLINICAL THERMOMETER TREND MEDICAL, INC.
K780725 05/03/1978 CENTRIA CORTISOL RIA UNION CARBIDE CORP.
K780765 05/05/1978 PERCUTANEOUS SURAPUBIC CATHETER VANCE PRODUCTS, INC.
K780851 05/22/1978 CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC VARIAN ASSOC., INC.
K780852 05/22/1978 CLINITEX VIS-X ASPIRATING ACCESSORY VARIAN ASSOC., INC.
K780864 05/30/1978 DIAMOND STONES VENTURE TECHNOLOGY, INC.
K780734 05/02/1978 ANTICONVULSANTS II CALIBRATOR KIT VITEK SYSTEMS, INC.
K780733 05/02/1978 ANTICONVULSANTS III CALIBRATOR KIT VITEK SYSTEMS, INC.
K780731 05/02/1978 LIDOCAINE CALIBRATOR KIT VITEK SYSTEMS, INC.
K780732 05/02/1978 PROCAINAMIDE CALIBRATOR KIT VITEK SYSTEMS, INC.
K780850 05/22/1978 SEARLE NEONATAL OXYGEN PROBE WILL ROSS CO.
K780752 05/08/1978 PROPHYLAXIS ANGLE YOUNG DENTAL MANUFACTURING CO 1, LLC.


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