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510(k) Data Aggregation

    K Number
    K963141
    Device Name
    KUGEL HERNIA PATCH
    Manufacturer
    DOUGLAS BUESCHEL
    Date Cleared
    1996-10-11

    (59 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOUGLAS BUESCHEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.
    Device Description
    The Kugel Hernia Patch™ is a surgical mesh for reinforcement of a hernia defect.
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