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    K Number
    K060409
    Device Name
    HEMOHALT HEMOSTASIS PAD
    Manufacturer
    VANSON-HALOSOURCE, INC.
    Date Cleared
    2006-05-17

    (90 days)

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

    VANSON-HALOSOURCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HemoHalt Hemostasis Pad is intended for the local management and rapid control of bleeding (hemostasis): for skin surface puncture sites for vascular procedures, percutaneous catheters and/or tubes; following hemodialysis treatments; for patients on anticoagulation therapy; and for lacerations, and nose bleeds. For use only on external bleeding wounds.
    Device Description
    HemoHalt™ Hemostasis Pad is a soft, non-woven pad approximately 5 x 5 x 0.5cm in size, made of chitosan, a polysaccharide heteropolymer of poly-Dglucosamine and poly-N-acetyl-D-glucosamine. The HemoHalt™ Hemostasis Pad will be packaged in a paper surfaced, high barrier foil pouch for single use and terminally sterilized by E-beam radiation.
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