510(k) K102965

CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI by Medtrade Products , Ltd. — Product Code QSY

K102965 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI". The FDA issued a decision of Substantially Equivalent on December 8, 2010. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.