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

    HAND DRILL, MODEL 11-9901-7

    K Number: K022712 · Decision Nov 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    16
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    HAND DRILL, MODEL 11-9901-7
    K Number
    K022712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Design, LLC
    Date Received
    August 14, 2002
    Decision Date
    November 12, 2002
    Product Code
    HBG
    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
    HBG Drills, Burrs, Trephines & Accessories (Manual)

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