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

    GORE BURR HOLE COVER

    K Number: K960656 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    28
    Applicant Total
    163
    Review Days
    181

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    Basic Information

    Device Name
    GORE BURR HOLE COVER
    K Number
    K960656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    February 15, 1996
    Decision Date
    August 14, 1996
    Product Code
    GXR
    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
    GXR Cover, Burr Hole

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