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FDA 510(k), K102965, CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
FDA 510(k), K102965, CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
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510(K) Number: K102965
Device Name: CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
Manufacturer: JONATHAN D RANFIELD
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number: QSY
Classification Product Code: KXA
Date Received: 10/05/2010
Decision Date: 12/08/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
Manufacturer: JONATHAN D RANFIELD
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number: QSY
Classification Product Code: KXA
Date Received: 10/05/2010
Decision Date: 12/08/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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