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

    GORETEX SAM FACIAL IMPLANT

    K Number: K942280 · Decision Jul 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    64
    Applicant Total
    127
    Review Days
    79

    Basic Information

    Device Name
    GORETEX SAM FACIAL IMPLANT
    K Number
    K942280
    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
    May 10, 1994
    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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