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510(k) Data Aggregation

    K Number
    K110172
    Device Name
    SONAFINE WOUND DRESSING
    Manufacturer
    STRATUS PHARMACEUTICAL
    Date Cleared
    2011-08-19

    (211 days)

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

    STRATUS PHARMACEUTICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SONAFINE® Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, superficial wounds, first and second degree burns and donor sites to include: - Radiation Dermatitis - Various types of dermatoses - Atopic dermatitis - Allergic contact dermatitis - Dry waxy skin SONAFINE® Wound Dressing maintains a moist wound and skin environment. Indications for OTC use: SONAFINE® Wound Dressing is indicated for the management of minor cuts, minor burns, and minor lacerations. SONAFINE® Wound Dressing maintains a moist wound and skin environment.
    Device Description
    SONAFINE® Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
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