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

    PRECLUDE SYNBLOC MEMBRANE

    K Number: K961802 · Decision Jul 31, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    163
    Review Days
    83

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    Basic Information

    Device Name
    PRECLUDE SYNBLOC MEMBRANE
    K Number
    K961802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5900
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    May 9, 1996
    Decision Date
    July 31, 1996
    Product Code
    GXO
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXO Strip, Craniosynostosis, Preformed

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    CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1

    FDA 510(k)
    FDA Class 2 ·Neurology
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