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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

    Total pages: 161
    Fully redacted pages: 111
    Content pages: 50

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