Premarket Submissions

DEVICE NAME APPLICANT K NUMBER SUBMISSION TYPE PRODUCT CODE
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR THE KENDAL CO. K000087 Traditional FOZ
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS SYNTHES (USA) K000089 Traditional HWC
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES GUTHRIE MEDICARE PRODUCTS (MELAKA) SDN BHD K000090 Traditional LYY
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT HOWMEDICA OSTEONICS CORP. K000091 Traditional JWH
MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. K000094 Special MNH
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM THE OLYMPUS OPTICAL CO. K000095 Traditional LFL
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 ROCHE DIAGNOSTICS CORP. K000096 Traditional LAF
GSI 2000 MIDDLE EAR ANALYZER GRASON-STADLER, INC. K000097 Abbreviated ETY
SOFTLINE SPRING CLIP NOVARE SURGICAL SYSTEMS, INC. K000098 Traditional DXC
CAMLOG SCREW IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES K000099 Special DZE
CAMLOG ROOTFORM IMPLANT SYSTEM ALTATEC BIOTECHNOLOGIES K000100 Special DZE
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER GUIDANT CORP. K000101 Special LIT
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 TECO DIAGNOSTICS K000102 Special CFR
AVL OPTI R ANALYZER AVL SCIENTIFIC CORP. K000103 Traditional CHL
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), MEDTRONIC VASCULAR K000105 Traditional GZF
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES FOTONA D.D. K000106 Traditional GEX
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 BHK HOLDING K000108 Traditional EMX
ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 DENTSPLY INTL. K000112 Traditional EIA
PROVEN KNEE SYSTEM STELKAST COMPANY K000113 Traditional JWH
RS-4M+MUSCLE STIMULATOR RS MEDICAL K000114 Traditional IPF
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