FDA 510(k) Applications Received During July, 1976

FDA 510(k) Number Submission Date Device Name Applicant Contact
K760327 07/27/1976 WHEEL'N WEIGH ACME MEDICAL SCALE CO.
K760158 07/02/1976 NEEDLES AND SUTURES, SILK & NYLON ALCON LABORATORIES
K760210 07/12/1976 BLANKET, WATER-JEL FIRE AMERICAN SAFETY
K760201 07/08/1976 X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC AMERICAN SCIENCE AND ENGINEERING, INC.
K760207 07/09/1976 KIT, FOLATE RADIOASSAY SC.7 AMERSHAM CORP.
K760280 07/23/1976 ELECTRODE SERIES 1401 ANDOVER MEDICAL, INC.
K760165 07/06/1976 FILTER, INFUSION BLOOD (1 PFF-100) BENTLEY LABORATORIES, INC.
K760162 07/06/1976 HEMATOLOGY CONTROL BIOLOGICAL CORP. OF AMERICA
K760272 07/22/1976 CIRCUIT, PRINTED, SERVO-MECHANISM BURDICK CORP.
K760265 07/22/1976 ELCTROCARDIOGRAPH, EK-6 BURDICK CORP.
K760268 07/22/1976 ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC. BURDICK CORP.
K760271 07/22/1976 ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS) BURDICK CORP.
K760266 07/22/1976 MONITOR, ELECTROCARDIOSCOPE BURDICK CORP.
K760275 07/22/1976 TREADMILL (TMS-300) BURDICK CORP.
K760204 07/08/1976 BUTTONS, PMMA (FOR CONTACT LENSES) BURTON PARSONS & CO., INC.
K760217 07/12/1976 SUCTION INSTRUMENT, MACBICK DIS. FRAZ. C.R. BARD, INC.
K760216 07/12/1976 SUCTION INSTRUMENT, MACBICK POOLE TIP C.R. BARD, INC.
K760254 07/19/1976 TRAY, FOLEY CATHETER C.R. BARD, INC.
K760253 07/19/1976 TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG C.R. BARD, INC.
K760228 07/13/1976 ANESTHESIA MACHINE, CHEMETRON CHEMETRON HEALTH SYSTEMS
K760159 07/02/1976 AGGREGOMETER, DUAL CHANNEL PLATELET CHRONO-LOG CORP.
K760198 07/06/1976 KIT, PLATELET AGGREGATION REAGENT (#390) CHRONO-LOG CORP.
K760251 07/19/1976 SET, ORAL ADMINISTRATION CIS RADIOPHARMACEUTICALS, INC.
K760252 07/19/1976 DIALYZER, HF 130 HOLLOW FIBER COBE LABORATORIES, INC.
K760226 07/12/1976 PASTE, ACCOE IMPRESSION COE LABORATORIES, INC.
K760225 07/12/1976 PUTTY, ACCOE COE LABORATORIES, INC.
K760256 07/19/1976 TEST SYSTEM, RIA CORTISOL CORNING MEDICAL & SCIENTIFIC
K760197 07/06/1976 ACCUVETTE II COULTER ELECTRONICS, INC.
K760196 07/06/1976 ASSAY, AMPHET. NDC#11711-0127-1 COULTER COULTER ELECTRONICS, INC.
K760194 07/06/1976 NDC#12739-0010-1 C-ZYME GPT COULTER ELECTRONICS, INC.
K760193 07/06/1976 NDC#12739-0011-1 C-ZYME GOT COULTER ELECTRONICS, INC.
K760195 07/06/1976 REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 COULTER ELECTRONICS, INC.
K760231 07/14/1976 IMPRESSION MATERIAL, DENTAL SILICON RTV CROWN DELTA CORP.
K760236 07/15/1976 BUR, SURGICAL CARBIDE CUTTER LABORATORIES, INC.
K760235 07/15/1976 SUTURE GUIDE CUTTER LABORATORIES, INC.
K760318 07/26/1976 ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.
K760248 07/19/1976 GLOVES, APARTICULATE SURGICAL DEKNATEL, INC.
K760311 07/26/1976 INSTRUMENTS, GENERAL HAND & SURGERY DEPUY, INC.
K760334 07/29/1976 PROSTEHSIS, TOTAL KNEE REPLACEMENT DEPUY, INC.
K760200 07/08/1976 PROSTHESIS, PATELLAR ARTICULAR SURFACE DEPUY, INC.
K760326 07/26/1976 SURGICAL INSTRUMENTS, OPTHALMIC DEPUY, INC.
K760325 07/26/1976 SURGICAL INSTRUMENTS, ORTHOPEDIC DEPUY, INC.
K760320 07/26/1976 PROTECTOR, SURGICAL INSTRUMENT DEVON INDUSTRIES, INC.
K760328 07/27/1976 RAZOR, DISPOSABLE DEVON INDUSTRIES, INC.
K760262 07/21/1976 RADIOASSY KIT, 3H-FOLATE DIAMOND SHAMROCK CORP.
K760258 07/20/1976 BITE STICK, DYNA DYNA-MED
K760167 07/06/1976 BAG, POST OPERATIVE LUNG EXERCIZING BLOW DYTEK CORP.
K760168 07/06/1976 PENCIL, ELECTROSURGICAL DYTEK CORP.
K760151 07/01/1976 APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) EDWARDS LABORATORIES
K760192 07/06/1976 COMPUTER, THERMODILUTION CARDIAC (9520) EDWARDS LABORATORIES
K760152 07/01/1976 FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) EDWARDS LABORATORIES
K760157 07/02/1976 SPHYGMOMANOMETER EYVIRCO
K760166 07/06/1976 STIMULATOR, SONIC CONTROL (AS-1) FARRALL INSTRUMENTS, INC.
K760263 07/21/1976 I.P.P.B. MANIFOLD/NEBULIZER (CIRCUIT) FOREGGER
K760296 07/23/1976 ADJUSTER, WHEELCHAIR WIDTH, BK-6470 FRED SAMMONS, INC.
K760305 07/23/1976 BALLOONS, BK-8112, 8114 FRED SAMMONS, INC.
K760289 07/23/1976 BRUSH, DISPOSA-A (HANDLE, REFILL PKG) FRED SAMMONS, INC.
K760287 07/23/1976 BUTTON AID W/POCKET CLIP, BK-2011 FRED SAMMONS, INC.
K760290 07/23/1976 CANE OR CRUTCH PARKER (3/4, 7/8, L") FRED SAMMONS, INC.
K760304 07/23/1976 CANOPY, PARACHUTE, BK-8110 FRED SAMMONS, INC.
K760306 07/23/1976 CARDS, GIANT FACE PLAYING BK-9419 FRED SAMMONS, INC.
K760295 07/23/1976 CARPET COVERS FOR FOOTRESTS, BK-6467 FRED SAMMONS, INC.
K760297 07/23/1976 CARRIER, FOLDING LUGGAGE, BK-6511 FRED SAMMONS, INC.
K760285 07/23/1976 CONE, HAND, BK-1501 FRED SAMMONS, INC.
K760281 07/23/1976 CUP HOLDER/CUP, WHEELCHAIR FRED SAMMONS, INC.
K760282 07/23/1976 CUP HOLDER/CUP,BK-1140 FRED SAMMONS, INC.
K760292 07/23/1976 DESK, BEANBAG SHUFFLE, BK-6059 FRED SAMMONS, INC.
K760303 07/23/1976 FORK, TUNING BK-7519 FRED SAMMONS, INC.
K760284 07/23/1976 GLASS, NOSEY CUTOUT, BK-1146 FRED SAMMONS, INC.
K760283 07/23/1976 GLASS, SIP N' STRAW WITH LID, 1143 FRED SAMMONS, INC.
K760302 07/23/1976 GONIOMETER, INTER. STAND. LARGE, BK7514 FRED SAMMONS, INC.
K760301 07/23/1976 GONIOMETER, MED. INTER. STAND. BK-7512 FRED SAMMONS, INC.
K760291 07/23/1976 HOLDER, PENCIL & CRAYON, WITH STAND FRED SAMMONS, INC.
K760294 07/23/1976 LEVERS, DOOR KNOB, BK-6395 FRED SAMMONS, INC.
K760293 07/23/1976 MIRROR, EXTEND-A-, BK-6235 FRED SAMMONS, INC.
K760300 07/23/1976 PADDING, TEMPER STICK FOAM, BK-7175 FRED SAMMONS, INC.
K760286 07/23/1976 SPOON, SOFT FOOD FEEDER, BK-1473 FRED SAMMONS, INC.
K760299 07/23/1976 STRIP, CLOSED CELL FOAM, BK-7171 FRED SAMMONS, INC.
K760298 07/23/1976 SUPPORT, WRIST, FIRM WIRE-FOAM FRED SAMMONS, INC.
K760288 07/23/1976 VIEWER, RECLINING, BK-4089 FRED SAMMONS, INC.
K760170 07/06/1976 INTRAUTERINE SOUND, PLASTIC DISPOSABLE G.D. SEARLE AND CO.
K760315 07/26/1976 PAD, POLYETHER FOAM, OPEN CELL GAYMAR INDUSTRIES, INC.
K760314 07/26/1976 FLOWMETER, OXYGEN HARRIS-LAKE, INC.
K760333 07/29/1976 JAR, COLLECTOR FOR SUCTION SYSTEMS HARRIS-LAKE, INC.
K760317 07/26/1976 REGULATORS, HIGH SUCTION HARRIS-LAKE, INC.
K760316 07/26/1976 REGULATORS, LOW SUCTION HARRIS-LAKE, INC.
K760169 07/06/1976 DIFFUSION SYSTEM, SINGLE-BREATH (47404A) HEWLETT-PACKARD CO.
K760150 07/01/1976 MONITOR, PATIENT (MODEL 78331A) HEWLETT-PACKARD CO.
K760160 07/02/1976 MONITOR, PATIENT (MODEL 78333A) HEWLETT-PACKARD CO.
K760330 07/28/1976 CANNULA, DISPOSABLE OXYGEN TTHERAPY INHAL-O-TECH MEDICAL PLASTIC
K760329 07/28/1976 MASK, DISPOSABLE OXYGEN THERAPY INHAL-O-TECH MEDICAL PLASTIC
K760313 07/26/1976 KIT, PREP, INSPIRON IV INSPIRON CORP.
K760211 07/12/1976 ANALYZER, GLUCOSE/UREA/CREATININE INSTRUMENTATION LABORATORY CO.
K760208 07/09/1976 OXIMETER, CO-, IL MODEL 282 INSTRUMENTATION LABORATORY CO.
K760232 07/14/1976 PRINTER, IL 460 INSTRUMENTATION LABORATORY CO.
K760233 07/14/1976 TABLE, SAMPLE IL 461 INSTRUMENTATION LABORATORY CO.
K760260 07/20/1976 BAG, DISPOSABLE URINARY LEG INTERMED, INC.
K760206 07/09/1976 TEST, DETECTION, ANTINUCLEAR ANTIBODIES INTL. DIAGNOSTIC TECHNOLOGY
K760202 07/08/1976 TUBE, STERILE CONDUCTIVE CONNECTING IPCO CORP.
K760203 07/08/1976 TUBE, STERILE NON-CONDUCTIVE CONNECTING IPCO CORP.
K760319 07/26/1976 KIT, CATHETER JELCO LABORATORIES
K760250 07/19/1976 BANDAGE, TRIANGULAR NO. 8068 JOHNSON & JOHNSON PROFESSIONALS, INC.
K760277 07/23/1976 UNDERPAD CODE NO. 8453 JOHNSON & JOHNSON PROFESSIONALS, INC.
K760227 07/12/1976 RADIOIMMUNOASSAY KALLESTAD LABORATORIES, INC.
K760343 07/30/1976 TRAY, CURITY CONTINUOUS EPIDURAL KENDALL RESEARCH CENTER
K760324 07/26/1976 BONDING AGENT, PRESTIGE LEE PHARMACEUTICALS
K760331 07/28/1976 TURBINE, AIR DRIVEN HANDPIECE (2000) LITTON DENTAL PRODUCTS
K760199 07/07/1976 ELECTRORETINOGRAPH LKC TECHNOLOGIES, INC.
K760279 07/23/1976 X-RAY FILM, CONVEY OR SYSTEM MALLINCKRODT GROUP, INC.
K760218 07/12/1976 CANNULAE, PLASTIC DISPOSABLE NASAL MANNER MEDICAL PRODUCTS
K760221 07/12/1976 I.P.P.B., DIS. W/MANIFOLD/NEBULIZER MANNER MEDICAL PRODUCTS
K760219 07/12/1976 MASKA, OXYGEN VINYL D-SP. SINGLE USE MANNER MEDICAL PRODUCTS
K760220 07/12/1976 TUBING, SINGLE USE OXYGEN SUPPLY MANNER MEDICAL PRODUCTS
K760242 07/15/1976 PROBECOT II MEASUREMENT-SCIENCE CORP.
K760223 07/12/1976 SCANNER, ULTRASOUND BODY/HEART MEDISCRA, INC.
K760278 07/23/1976 SLIDE, LAB-TEK COVERED MICRO MILES LABORATORIES, INC.
K760264 07/21/1976 CURETTE, PROPOSED TIS-U-TRAP, METAL MILEX PRODUCTS, INC.
K760341 07/30/1976 HUMIDIFIER, ELECTRONIC (EH147) MISTOGEN EQUIPMENT CO.
K760312 07/26/1976 ELECTRODE, PNS NDM CORP.
K760214 07/12/1976 STIMULATOR, PNEUMATIC O. F. ANDERSON
K760230 07/14/1976 VALVE, PEEP OHIO MEDICAL PRODUCTS
K760239 07/15/1976 CEMENT, ULTRA-BOND ORATEC DENTAL PRODUCTS
K760238 07/15/1976 IMPRESSION MATERIAL, TRIFLEX SILICONE ORATEC DENTAL PRODUCTS
K760240 07/15/1976 IMPRESSION MATERIAL, TRIFLEX SILICONE ORATEC DENTAL PRODUCTS
K760234 07/15/1976 OXIMETER, IN VIVO CATHETER OXIMETRIX, INC.
K760342 07/30/1976 RAZOR, SCHICK DISPOSABLE PARKE-DAVIS CO.
K760164 07/06/1976 UNDERPAD, DISPOSABLE POLYPROPY. (UNILUX) PARKE-DAVIS CO.
K760171 07/06/1976 FIBERBRONCHOSCOPE (PENTAX FB-17A) PILLING CO.
K760161 07/02/1976 TEST, ACID PHOSPHATASE PRINCETON BIOMEDIX
K760237 07/15/1976 GOWN, BOUNDARY SINGLE USE REINFORCED PROCTER & GAMBLE MFG. CO.
K760213 07/12/1976 LENSES, CONTACT, POLYMETHYL METHACRYLATE PROGRESSIVE AFFILIATED LABS, INC.
K760244 07/16/1976 RADIOEAR, PERSONAL RADIOEAR CORP.
K760335 07/29/1976 NEBULIZER, MICRO (ADDI-MIST) RESPIRATORY CARE, INC.
K760245 07/19/1976 PROSTHESIS, RICHARDS MOD II KNEE RICHARD'S MEDICAL EQUIP., INC.
K760257 07/19/1976 SPONGE, RICHARDS WOUND DRAINAGE SYSTEM RICHARD'S MEDICAL EQUIP., INC.
K760337 07/30/1976 CANNULA, ARGYLE NASAL OXYGEN SHERWOOD MEDICAL INDUSTRIES
K760246 07/19/1976 ENDOTRACHEAL T CONNECTOR SHERWOOD MEDICAL INDUSTRIES
K760338 07/30/1976 MONITOR, RESP. OXYGEN (TOP) SHERWOOD MEDICAL INDUSTRIES
K760339 07/30/1976 MONITOR, RESPIRATORY (CPAP) SHERWOOD MEDICAL INDUSTRIES
K760340 07/30/1976 RESPIRATORY SUPPORT SYSTEM, NEONATAL SHERWOOD MEDICAL INDUSTRIES
K760247 07/19/1976 GLUCOSE REAGENT SYS, SIGMA PROCED. 115 SIGMA CHEMICAL CO.
K760332 07/28/1976 SIGMA AMMONIA REAGENT SIGMA CHEMICAL CO.
K760212 07/12/1976 DRAPES, BARRIER, STERILE PATIENT READY SURGIKOS, INC.
K760222 07/12/1976 FILTER, TRANSFUSION BLOOD, INTERSEPT SURGIKOS, INC.
K760307 07/26/1976 BEDPAN, SINGLE PATIENT USE, TECNOL TECNOL NEW JERSEY WOUND CARE, INC.
K760308 07/26/1976 I.V. SUPPORT, TECNOL ARMBOARD TECNOL NEW JERSEY WOUND CARE, INC.
K760309 07/26/1976 LIMB HOLDER, TECNOL REMINDER TECNOL NEW JERSEY WOUND CARE, INC.
K760229 07/14/1976 ACID BASE SYSTEM, RADIOMETER AUTOMATED THE LONDON CO.
K760261 07/19/1976 DETECTOR, MODEL LC-100 FLUORESCENCE THE PERKIN-ELMER CORP.
K760322 07/26/1976 CHAIR, ATTACHED INSTRUMENT DEL. SYS. THE S. S. WHITE CO.
K760321 07/26/1976 CHAIR, DENTAL OPERATIVE THE S. S. WHITE CO.
K760323 07/26/1976 X-RAY UNIT, DENTAL DIAGNOSTIC THE S. S. WHITE CO.
K760259 07/20/1976 CATHETER 3-WAY SILICONE FOLEY TRAVENOL LABORATORIES, S.A.
K760243 07/16/1976 GLOVES, STERILE LATEX SURGEON'S TRAVENOL LABORATORIES, S.A.
K760249 07/19/1976 TRAY, STERILE DISPOSABLE ARTHROGRAM TRAVENOL LABORATORIES, S.A.
K760174 07/06/1976 ADAPTER, RESECTOSCOPE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760173 07/06/1976 BRIDGE, SHORT DEFLECTING V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760186 07/06/1976 DISSECTOR, TROUTMAN CORNEAL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760175 07/06/1976 DRAPE, TRANSURETHRAL RESECTION (TUR) V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760178 07/06/1976 ELECTRODE, CUTTING LOOP V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760184 07/06/1976 ELEMENT, WORKING V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760176 07/06/1976 FLOORSTAND, FIBER OPTIC LIGHT SOURCE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760180 07/06/1976 FORCEPS, GRASPING V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760191 07/06/1976 KNIFE, TROUTMAN CORNEAL LARGE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760187 07/06/1976 KNIFE, TROUTMAN CORNEAL SMALL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760273 07/22/1976 LITHOTRITE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760183 07/06/1976 OBTURATOR, DEFLECTING V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760172 07/06/1976 OBTURATOR, VISUAL V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760190 07/06/1976 SCISSORS, IRIS STRAIGHT V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760188 07/06/1976 SCISSORS, MICRO IRIS CURVED V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760185 07/06/1976 SCISSORS, MICRO IRIS STRAIGHT V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760179 07/06/1976 SHEATH, CYSTOURETHROSCOPE W/ OBTURATOR V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760182 07/06/1976 SHEATH, RESECTOSCOPE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760189 07/06/1976 STOPCOCK, WATERLINE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760177 07/06/1976 TELESCOPE, RIGID ENDOSCOPE V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760274 07/22/1976 TIP, RUBBER, PERFORATED V. MUELLER O.V. BAXTER HEALTHCARE CORP.
K760215 07/12/1976 HEARING AID, S-522 FM VICON INSTRUMENT CO.
K760336 07/30/1976 BIOCEPT-G WAMPOLE LABORATORIES
K760205 07/09/1976 RADIOGRAPHIC UNIT, XRC-1 XRC, INC.
K760209 07/09/1976 ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP ZEUS SCIENTIFIC, INC.
K760153 07/02/1976 TEST, (IVDP) ANTINUCLEAR ANTIBODY ZEUS SCIENTIFIC, INC.
K760155 07/02/1976 TEST, (IVDP) MITOCHONDRIAL ANTIBODY ZEUS SCIENTIFIC, INC.
K760156 07/02/1976 TEST, (IVDP) SMOOTHMUSCLE ANTIBODY ZEUS SCIENTIFIC, INC.
K760154 07/02/1976 TEST, (IVDP) THYROID ANTIBODY ZEUS SCIENTIFIC, INC.


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