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510(k) Data Aggregation

    K Number
    K122634
    Device Name
    IODOFOAM IODOPHOR FOAM DRESSING
    Manufacturer
    PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC
    Date Cleared
    2013-03-12

    (195 days)

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

    PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.
    Device Description
    Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted
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