FDA 510(k) Applications Received During September, 1979

FDA 510(k) Number Submission Date Device Name Applicant Contact
K791894 09/25/1979 3M BRAND TOTAL LEG COMPRESSION TLC SYS. 3M COMPANY
K791789 09/14/1979 3M MICROBIAL PROFILE SYSTEM GRAM 3M COMPANY
K791823 09/14/1979 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM 3M COMPANY
K791914 09/25/1979 3-WAY STOPCOCK W/MALE LOCKING LUER ADA. ABBOTT LABORATORIES
K791796 09/14/1979 ADDITIVE HINGE CAP ABBOTT LABORATORIES
K791747 09/10/1979 HTSH NEONATE RIA DIAGNOSTIC KIT ABBOTT LABORATORIES
K791930 09/27/1979 IV EXTENSION SET SL ABBOTT LABORATORIES
K791774 09/10/1979 LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN ABBOTT LABORATORIES
K791746 09/10/1979 ROTAZYME ABBOTT LABORATORIES
K791891 09/25/1979 ACU-MED RED MISER HEMOTHORAX BLOOD COLL. ACUMED INSTRUMENTS CORP.
K791757 09/05/1979 CERVICAL ORTHOPEDIC PILLOW ADELINE V. SANTORO
K791933 09/27/1979 CONVERSION CONTRACTOR TIMER KIT ADVANCED INSTRUMENT DEVELOPMENT, INC.
K791856 09/19/1979 "Y" & ELBOW W/WO PORTS AIRLIFE, INC.
K791819 09/14/1979 AIR INCENTIVE SPIROMETER AIRLIFE, INC.
K791761 09/05/1979 CIRCUIT, BREATHING W/WO NEBULIZER AIRLIFE, INC.
K791821 09/14/1979 CORRUGATED FLEXIBLE POLYETHYLENE & EVA AIRLIFE, INC.
K791820 09/14/1979 I.P.P.B. MANIFOLDS & NEB. SING. & DBL AIRLIFE, INC.
K791785 09/11/1979 MEKTOEN ENTERIC AGAR 100X15MM PLATE AMERICAN LABORATORY SUPPLY, INC.
K791786 09/11/1979 SALMONELLA SHIGELLA AGAR PLATE AMERICAN LABORATORY SUPPLY, INC.
K791787 09/11/1979 XYLOSE LYSINE DESOXYCHOLATE AGAR PLATE AMERICAN LABORATORY SUPPLY, INC.
K791825 09/17/1979 "LY-PRO-TROL" #ACS-LP101 ANALYTICAL CONTROL SYSTEMS, INC.
K791861 09/24/1979 OXYGEN HOODS ANN ARBOR PLASTICS, INC.
K791888 09/11/1979 CATHETER CARE KIT REORDER 7940&7941 ASCEP, INC.
K791887 09/11/1979 CENTRAL VENOUS CATHETER DRESSING TRAY ASCEP, INC.
K791886 09/11/1979 I.V. CARE KIT ASCEP, INC.
K791885 09/11/1979 I.V. START SET ASCEP, INC.
K791889 09/11/1979 SUTURE REMOVAL TRAY, REORDER 7950&7951 ASCEP, INC.
K791901 09/25/1979 BARNES-HIND WETTING & SOAKING SOLUTION BARNES-HIND, INC.
K791866 09/21/1979 STANDARD HEALTH BIKE MODEL 019 BATTLE CREEK EQUIPMENT CO.
K791834 09/17/1979 NURITE II VRM DUAL (ELEC. NERVE STIM.) BIO-MEDICAL SYSTEMS CORP.
K791833 09/17/1979 NURITE II VRM SINGLE (ELEC. NERVE STIM) BIO-MEDICAL SYSTEMS CORP.
K791770 09/07/1979 QUANTIMUNE GENTAMICIN RIA GENTAMICIN BIO-RAD
K791836 09/14/1979 QUANTIMUNE HFSH RIA BIO-RAD
K791837 09/14/1979 VMA BY COLUMN TEST BIO-RAD
K791782 09/12/1979 USCI BALLOON DILATATION INFLATION DEV. C.R. BARD, INC.
K791793 09/14/1979 USCI PRESSURE GAUGE C.R. BARD, INC.
K791873 09/21/1979 USCI SAFE-T-CLOTH THERMODILUTION CAT. C.R. BARD, INC.
K791870 09/21/1979 DISPOSABLE SPECIALITY SPONGES CARWILD CORP.
K791872 09/21/1979 LAP SPONGES CARWILD CORP.
K791871 09/21/1979 NEUROLOGICAL SPONGES (PATTIES) CARWILD CORP.
K791860 09/19/1979 FERRITIN RIA KIT CIS RADIOPHARMACEUTICALS, INC.
K791826 09/17/1979 CPK CLINI GEL KIT CLINICAL SCIENCES, INC.
K791749 09/10/1979 INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL CLINICAL SCIENCES, INC.
K791827 09/17/1979 LDH CLINI GEL KIT CLINICAL SCIENCES, INC.
K791978 09/28/1979 SUGITA ANEURYSM CLIPS, APPLIERS & CASE CODMAN & SHURTLEFF, INC.
K791895 09/25/1979 ACCESSORIES FOR SYS. 400 CO2 SURG. LASER COHERENT MEDICAL DIVISION
K791806 09/13/1979 CONPHAR ADAPT-CONNECTS STERILE, NONSTE. CONPHAR, INC.
K791799 09/13/1979 CONPHAR AIRWAYS CONPHAR, INC.
K791803 09/13/1979 CONPHAR CATHETER PLUG CONPHAR, INC.
K791805 09/13/1979 CONPHAR EXAM. GLOVES, POLYETHYLENE CONPHAR, INC.
K791801 09/13/1979 CONPHAR FINGERTIP SUCTION CONTROL CONPHAR, INC.
K791798 09/14/1979 CONPHAR SURGICAL RAZORR CONPHAR, INC.
K791802 09/13/1979 CONPHAR TUBE CLAMPS CONPHAR, INC.
K791800 09/13/1979 CONPHAR UMBILICAL CORD CLAMP CONPHAR, INC.
K791917 09/25/1979 X-PAK CONTEMPORARY SURGICAL SYSTEMS, INC.
K791898 09/25/1979 OCUTOME MODEL 8000 COOPER MEDICAL DEVICES CORP.
K791784 09/12/1979 CORDIS BIPOLAR PACER CONNECTOR SYSTEM CORDIS CORP.
K791768 09/05/1979 CORDIS PERMANENT PERVENOUS CARDIAC LEADS CORDIS CORP.
K791783 09/11/1979 OMNI-STANICOR (THETA) MOD 237A CORDIS CORP.
K791777 09/10/1979 CORNING GLYCOSYLATED HEMOGLOBIN SET CORNING MEDICAL & SCIENTIFIC
K791903 09/25/1979 COULTER DIFF3 SYS. (COULTER #7400003) COULTER ELECTRONICS, INC.
K791832 09/18/1979 VEIN GRAFT CANNULA D/P, INC.
K791922 09/26/1979 HARLECO BRAND CLINICARD LIPASE TEST SET DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K791925 09/27/1979 DEN-MAT 4-MINUTE DENTURE CLEANER DEN-MAT CORP.
K791759 09/05/1979 TEST PRESSURE GAUGE #6675-32 DEPUY, INC.
K791750 09/05/1979 COUNTER-CHECK PLUS DIAGNOSTIC TECHNOLOGY, INC.
K791772 09/07/1979 COUNTER-CHECK PLUS NORMAL, HIGH ABN. DIAGNOSTIC TECHNOLOGY, INC.
K791897 09/25/1979 BACTO-HATTS DIFCO LABORATORIES, INC.
K791846 09/19/1979 DISPOSSABLE SUCTION TUBE, 6 FRENCH DLP, INC.
K791808 09/11/1979 CERVI-TRAC DR. K.G. RUDE
K791845 09/19/1979 BAYONET HEIFETZ CLIP APPLIERS EDWARD WECK, INC.
K791742 09/10/1979 BROOKS GALL BLADDER SCISSORS (SURG) EDWARD WECK, INC.
K791982 09/25/1979 CANNULA'S CAT #'S 6636, 6624, 6625 EDWARD WECK, INC.
K791986 09/25/1979 FIX. & LENS FOR. #'S 3510,3512,3248,3795 EDWARD WECK, INC.
K791741 09/10/1979 FLOOR LINE INSTRUMENTS EDWARD WECK, INC.
K791985 09/25/1979 HOOKS #'S 7600,7602,7603,7616 EDWARD WECK, INC.
K791988 09/25/1979 REPL. PISTON FOR TROUTMAN CORNEAL PUNCH EDWARD WECK, INC.
K791984 09/25/1979 SCISSOR'S #'S 2294,2262,2263 EDWARD WECK, INC.
K791983 09/25/1979 SPATULA'S #'S 7618,7248,7240,7242,5108 EDWARD WECK, INC.
K791981 09/25/1979 SWAN KNIFE NEEDLE 1.5MM CAT # 1170 EDWARD WECK, INC.
K791980 09/25/1979 TOME'S #'S 1221,1222,1223,1314,6640,6642 EDWARD WECK, INC.
K791987 09/25/1979 VASCULAR FORCEPS & CLAMPS EDWARD WECK, INC.
K791743 09/10/1979 WECK RACK (STERILIZING ACCESSORY TRAY) EDWARD WECK, INC.
K791751 09/05/1979 EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR EDWARDS PACEMAKER SYSTEMS
K791857 09/19/1979 HOLLOW FIBER DIALIZER MODEL TRIEX-3 EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
K791760 09/05/1979 GLUCOSE HEXOKINASE COIL REAGENT SYSTEM FISHER SCIENTIFIC CO., LLC.
K791755 09/05/1979 DATASON-GS GENERAL ELECTRIC CO.
K791830 09/17/1979 L/U ARM - NEURO - VASCULAR #B5080B GENERAL ELECTRIC CO.
K791874 09/21/1979 CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD GILFORD DIAGNOSTICS
K791754 09/05/1979 URIC ACID REAGENT GILFORD DIAGNOSTICS
K791844 09/19/1979 CRITIFLO & CRITIFLO DOME GOULD, INC.
K791919 09/25/1979 BAC JAC HAGGIN INDUSTRIES, INC.
K791893 09/25/1979 19091-XXXXX SER. OF GLASS CAPILLARY COL. HEWLETT-PACKARD CO.
K791788 09/11/1979 MICRO-RING SYSTEM PRECISION ATTACH. HOWMEDICA CORP.
K791824 09/14/1979 ANTISERUM TO HUMAN IMMUNOGLOBULINS ICL SCIENTIFIC
K791810 09/14/1979 VASCULAR GRAFT PROST. OF EXPANDED PTFE IMPRA, INC.
K791892 09/25/1979 TAPE-A-TRACE INSTROMEDIX, INC.
K791763 09/05/1979 (MICRO-KERATRON, MICRO DUCT TREPHINE) INTL. OPHTHALMIC INDUSTRIES CORP.
K791814 09/14/1979 BILE ESCULIN AGAR ISLE MEDIA AND STERILE PRODUCTS, INC.
K791816 09/14/1979 DC AGAR (DESOXYCHOLATE CITRATE AGAR) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791813 09/14/1979 DNASE TEST AGAR W/METHYL GREEN ISLE MEDIA AND STERILE PRODUCTS, INC.
K791817 09/14/1979 MIO MEDIUM (MOTILITY INDOLE ORNITHINE) ISLE MEDIA AND STERILE PRODUCTS, INC.
K791815 09/14/1979 MUELLER HINTON CHOCOLATE ISLE MEDIA AND STERILE PRODUCTS, INC.
K791818 09/14/1979 MUELLER HINTON MEDIUM W/SHEEP BLOOD ISLE MEDIA AND STERILE PRODUCTS, INC.
K791936 09/27/1979 ATMOS ENT CABINET PRACTICA 2 JEDMED INSTRUMENT CO.
K791935 09/27/1979 ATMOS ENT CABINET PRACTICA 3 JEDMED INSTRUMENT CO.
K791937 09/27/1979 ATMOS ENT PATIENT CHAIR #1 JEDMED INSTRUMENT CO.
K791938 09/27/1979 ATMOS ENT PATIENT CHAIR #5 JEDMED INSTRUMENT CO.
K791934 09/27/1979 ATMOS ENT TREATMENT SYSTEM SERVANT 3 JEDMED INSTRUMENT CO.
K791766 09/10/1979 ECHO-OCULOMETER #3000 JEDMED INSTRUMENT CO.
K791918 09/25/1979 JELCO WINGED INTRAVASCULAR CATHETER JELCO LABORATORIES
K791928 09/27/1979 ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT KEITH E. ABBOTT
K791756 09/05/1979 VDC LIFE SCIENCES MANUFACTURING, INC.
K791863 09/24/1979 MAC LEE ENEMAD MAC LEE MEDICAL PRODUCTS
K791745 09/10/1979 MODEL H44-80 BEHIND THE EAR HEARING MARCON HEARING INSTRUMENTS, INC.
K791929 09/27/1979 WRIGHTS RAPID STAIN MCB MANUFACTURING CHEMISTS, INC.
K791795 09/14/1979 COMP-ACT IV MEDCRAFT CORP.
K791847 09/19/1979 "ASPRI-LUKE" MEDICAL MARKETING GROUP TIMOTHY GOLDEN
K791831 09/18/1979 PROCAST MEDICAL SPECIALTIES, INC.
K791797 09/14/1979 MTS CATHETER ADAPTER FOR GUIDANCE ENTRY MEDICAL TESTING SYSTEM, INC.
K791839 09/14/1979 H59 CRITICAL CARE MONITOR MEDTEL PTY. LTD.
K791838 09/14/1979 HSH/H512 ADULT PHYSIOLOGICAL MONITORS MEDTEL PTY. LTD.
K791769 09/05/1979 MEDTRONIC MODEL 6957 MEDTRONIC VASCULAR
K791778 09/10/1979 MEDTRONIC MODEL 9410 TELETRACE RECEIVER MEDTRONIC VASCULAR
K791911 09/25/1979 FALL-SAFE IMV #M-511 MEM MEDICAL, INC.
K791909 09/25/1979 IMV BUSHING #M-513 MEM MEDICAL, INC.
K791912 09/25/1979 IMV FOR MONITORING #M-510 MEM MEDICAL, INC.
K791913 09/25/1979 IMV MANIFOLD #M-506 MEM MEDICAL, INC.
K791906 09/25/1979 IMV W/BAG #M-507 MEM MEDICAL, INC.
K791904 09/25/1979 IMV W/BAG & HOSES #M-509 MEM MEDICAL, INC.
K791905 09/25/1979 IMV W/BAG & TUBING #M-508 MEM MEDICAL, INC.
K791850 09/19/1979 ONE-WAY VALVE-FEMALE, M-503 MEM MEDICAL, INC.
K791849 09/19/1979 ONE-WAY VALVE-MALE, M-504 MEM MEDICAL, INC.
K791851 09/19/1979 RED CAP, M-502 MEM MEDICAL, INC.
K791848 09/19/1979 RESPIROMETER MANIFOLD M-505 MEM MEDICAL, INC.
K791908 09/25/1979 RETARD VALVE 3-STACK #M-514 MEM MEDICAL, INC.
K791907 09/25/1979 RETARD VALVE 3-STACK #M-515 MEM MEDICAL, INC.
K791852 09/19/1979 T-PC FOR R.F. M.D., M-501 MEM MEDICAL, INC.
K791853 09/19/1979 TEE- TWO-WAY VALVES M-500 MEM MEDICAL, INC.
K791910 09/25/1979 THREE LITER BAG #M-512 MEM MEDICAL, INC.
K791869 09/20/1979 GLUCOSE OXIDASE (FRINDER) KIT MID TECH, INC.
K791771 09/07/1979 ORALUMINATOR III AUTO-LIGHT MIDWEST
K791865 09/21/1979 HYDRON BURN DRESSING FIELD KIT NATIONAL PATENT DEVELOPMENT CORP.
K791890 09/25/1979 CONTINUOUS FLUSH DEVICE, CAT. #14-370 NORTON PERFORMANCE PLASTICS CORP.
K791923 09/26/1979 SCLERAL POWDER OCULARISTS LTD.
K791781 09/11/1979 TUBE-STRAP OLYMPIC MEDICAL CORP.
K791791 09/11/1979 ORTHO ANTIBODY ENHANCEMENT SOLUTION ORTHO DIAGNOSTICS, INC.
K791732 09/05/1979 IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC OSCOR INC.
K791868 09/20/1979 OXIMETRIX SHAW HEMOSTATIC SURG. SYS. OXIMETRIX, INC.
K791748 09/10/1979 ULTIPOR BLOOD FILTER EXTRA-CORPOREAL PALL BIOMEDICAL PRODUCTS CO.
K791916 09/25/1979 PELICAN BAY KEL-COR CEPHALOMETRIC SYS. PELICAN BAY KEL-COR
K792369 09/24/1979 HYPERALIMENTATION DRESSING TRAY PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791773 09/10/1979 VENTILATOR TUBE WITH FILTER PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791809 09/17/1979 BLOOD TRANSFUSION MICROFILTER PIONEER VIGGO, INC.
K791843 09/19/1979 PONCY PAK PONCY, INC.
K791924 09/27/1979 PDC 104 SINGLE SWAB CULTURE COLLECTION PRECISION DYNAMICS CORP.
K791926 09/27/1979 HAND TOWEL PROCTER & GAMBLE MFG. CO.
K791864 09/21/1979 INSTRUMENT PAD PROCTER & GAMBLE MFG. CO.
K791842 09/19/1979 MOTIVATOR PURITAN BENNETT CORP.
K791915 09/25/1979 WHITE SEALING CAP QUINTON, INC.
K791835 09/17/1979 CORALENT COAT 125I CORTISOL RADIOIMM. RADIOASSAY SYSTEMS LABORATORIES, INC.
K791740 09/10/1979 SERUM 11-DESOXYCORTISOL I AS TRACER RADIOASSAY SYSTEMS LABORATORIES, INC.
K791753 09/05/1979 IPAG MICRONOVA INTERFACE #781111 ROBINTON CORP.
K791758 09/05/1979 CLINIFEEDING SYSTEM 1 ROUSSEL (CANADA) LTD.
K791867 09/21/1979 ROYCO MODEL 921 CELL COUNTER ROYCO INSTRUMENTS
K791792 09/13/1979 "SCI MED PERICARDIAL SUBSTITUTE" SCIMED LIFE SYSTEMS, INC.
K791828 09/17/1979 BJORK-SHILEY PULMONIC GRAFT VALVE SHILEY, INC.
K791829 09/17/1979 SHILEY QUICK DISCONNECT ASSEMBLY SHILEY, INC.
K791794 09/13/1979 FACTOR VII DEFICIENT PLASMA SIGMA CHEMICAL CO.
K791776 09/10/1979 ARRHYTHMIA II EDITOR SPACELABS, INC.
K791811 09/18/1979 SPECTRUM AUTOMATIC CHEST UNIT MODEL C SPECTRUM X-RAY CORP.
K791812 09/18/1979 SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM SPECTRUM X-RAY CORP.
K791726 09/04/1979 HYDROGEL-PREP SPENCO MEDICAL CORP.
K791862 09/24/1979 HEART RATE COMPUTER STANFORD ASSOC., INC.
K791927 09/27/1979 HEART RATE COMPUTER STRIP CHART STANFORD ASSOC., INC.
K791790 09/11/1979 MODEL TM5 BEHIND EAR TINNITUS MASKER STARKEY LABORATORIES, INC.
K791767 09/05/1979 BOVIE CSV HAND CONTROL ADAPTER SYBRON CORP.
K791979 09/25/1979 TECHNICON FAST-LC SYS. ANTICONVU DRUGS TECHNICON INSTRUMENTS CORP.
K791859 09/18/1979 TECNOL STIRRUPS STRAP TECNOL NEW JERSEY WOUND CARE, INC.
K791931 09/27/1979 PREHENSILE HAND THERAPEUTIC RECREATION SYSTEMS, INC.
K791900 09/25/1979 M015 OXYGEN & MA15 AIR TIMETER INSTRUMENT CORP.
K791858 09/19/1979 CARDIOPLEGIA ADMIN. SETS TRAVENOL LABORATORIES, S.A.
K791899 09/25/1979 CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 TRAVENOL LABORATORIES, S.A.
K791854 09/19/1979 CENTRIA HPL RIA UNION CARBIDE CORP.
K791855 09/19/1979 CENTRIA TSH RIA UNION CARBIDE CORP.
K791902 09/25/1979 LINDE OXYGEN WALKER SYS. MARK II-L UNION CARBIDE CORP.
K791822 09/14/1979 BIOGUARD INFUSION LINE FILTER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
K791752 09/05/1979 LECTROVAC, VALLEYLAB MODELS VALLEYLAB, INC.
K791775 09/10/1979 VARIAN V-3300, PHASED ARRAY ULTRASON VARIAN ASSOC., INC.
K791744 09/10/1979 VARIAN V-3400, PHASED ARRAY ULTRASON VARIAN ASSOC., INC.
K791896 09/25/1979 CENTRIA PHENYTOIN RIA TEST SET VENTREX LABORATORIES, INC.
K791921 09/25/1979 CARDIAC PACEMAKER "C4000, "C1000 SER. VITATRON MEDICAL BV
K791920 09/25/1979 CARDIAC PACEMAKER "P4000 SER. & "P1000 VITATRON MEDICAL BV
K791932 09/27/1979 AMS ENTEROBACTERIACEASE CARE VITEK SYSTEMS, INC.
K791875 09/21/1979 PARKE-DAVIS TOTAL HIP PROSTHESIS WARNER-LAMBERT CO.


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