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

    CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231

    K Number: K073336 · Decision Jan 4, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    17
    Applicant Total
    152
    Review Days
    37

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    Basic Information

    Device Name
    CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
    K Number
    K073336
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4305
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codman & Shurtleff, Inc.
    Date Received
    November 28, 2007
    Decision Date
    January 4, 2008
    Product Code
    HBF
    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
    HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)

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