BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    GORE-TEX FACIAL IMPLANT

    K Number: K933367 · Decision Jul 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    65
    Applicant Total
    163
    Review Days
    384

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    Basic Information

    Device Name
    GORE-TEX FACIAL IMPLANT
    K Number
    K933367
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    July 9, 1993
    Decision Date
    July 28, 1994
    Product Code
    FWP
    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
    FWP Prosthesis, Chin, Internal

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