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

    MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

    K Number: K071791 · Decision Jul 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    152
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
    K Number
    K071791
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    July 2, 2007
    Decision Date
    July 30, 2007
    Product Code
    GXP
    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
    GXP Methyl Methacrylate For Cranioplasty

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