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

    GORE-TEX MYCROMESH BIOMATERIAL

    K Number: K951675 · Decision Oct 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    163
    Review Days
    179

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    Basic Information

    Device Name
    GORE-TEX MYCROMESH BIOMATERIAL
    K Number
    K951675
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    April 11, 1995
    Decision Date
    October 7, 1995
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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