BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    UHMWPE SURGICAL MESH

    K Number: K894478 · Decision Mar 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    441
    Review Days
    233

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    Basic Information

    Device Name
    UHMWPE SURGICAL MESH
    K Number
    K894478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3500
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biomet, Inc.
    Date Received
    July 18, 1989
    Decision Date
    March 8, 1990
    Product Code
    KKY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

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