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510(k) Data Aggregation

    K Number
    K071442
    Device Name
    SUPRASORB A +AG
    Date Cleared
    2008-05-01

    (344 days)

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

    SPECIALTY FIBRES AND MATERIALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Suprasorb® A +Ag Calcium Alginate Dressing with Antibacterial Silver can be used for the management of wounds which are: Moderately and heavily exuding, Superficial or Deep, Such as: Pressure sores, Arterial Ulcers, Venous lower leg ulcers, Diabetic ulcers, Post-operative wounds.
    Device Description
    Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are soft, conformable wound covers with a high mannuronic acid content. The silver-impregnated calcium alginate fibres, when in contact with wound exudate or blood, form a gel which creates a moist wound healing environment. The silver in the wound dressing has an antibacterial effect upon various types of bacteria including Staphylococcus aureus and Escherichia Coli. The silver ions protect the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days in the in vitro challenge test. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are sterilized by irradiation and must not be re-sterilized. The products are sterile unless the package is opened or damaged. Suprasorb® A + Ag Calcium Alginate Dressings with Antibacterial Silver are for single use only.
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