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510(k) Data Aggregation

    K Number
    K112215
    Device Name
    HEMCON HEMOSTATIC GEL
    Manufacturer
    HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD.
    Date Cleared
    2012-04-12

    (254 days)

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

    HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx Only: HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds. OTC: HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.
    Device Description
    HemCon GuardaGel™ is intended for the management of wounds and for emergency external use in the temporary control of minor bleeding from the skin and other surface wounds where temporary control of bleeding is required. It is a homogenous aqueous, viscous opaque gel comprised of pectin, m.doc™ (HemCon's proprietary hemostatic oxidized cellulose formulation), potassium sorbate, glycerol and 5 %w/w ethanol. The gel comes in a sterile pre-filled syringe.
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