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510(k) Data Aggregation

    K Number
    K082601
    Device Name
    UltraClot, UltraClot OTC
    Manufacturer
    EMERGENCY MEDICAL DEVICES, LLC
    Date Cleared
    2008-10-09

    (31 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMERGENCY MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription, Rx UltraClot™ is intended as a hemostatic dressing for emergency external use and temporary wound treatment to achieve hemostasis of moderate to severe bleeding. Over the Counter, OTC UltraClot™ OTC is intended as a topical hemostatic dressing for the local management of bleeding from minor cuts, lacerations, and abrasions.
    Device Description
    UltraClot™ is a hemostatic agent comprising a clay-based powder contained in a dissolving pouch with a non-stick gauze pad backing that is placed on a moderate to severe wound and held in place until hemostasis is achieved. The device is packaged in a vacuum sealed foil bag and is provided sterile.
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