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510(k) Data Aggregation

    K Number
    K964620
    Device Name
    PANOGAUZE NON-WOVEN HYDROGEL DRESSING
    Manufacturer
    SAGE PHARMACEUTICALS, INC.
    Date Cleared
    1997-01-09

    (52 days)

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

    SAGE PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    intended to provide a moist packing/healing environment which helps to prevent wound desiccation.
    Device Description
    absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches.
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