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

    BURR HOLE COVER, MODEL XX

    K Number: K001096 · Decision Oct 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    28
    Applicant Total
    22
    Review Days
    204

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    Basic Information

    Device Name
    BURR HOLE COVER, MODEL XX
    K Number
    K001096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Image-Guided Neurologics, Inc.
    Date Received
    April 4, 2000
    Decision Date
    October 25, 2000
    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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