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

    SMALL HIGH SPEED MOTOR DRILL SYSTEM

    K Number: K030172 · Decision Apr 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    60
    Applicant Total
    4
    Review Days
    76

    Basic Information

    Device Name
    SMALL HIGH SPEED MOTOR DRILL SYSTEM
    K Number
    K030172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4310
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BRASSELER USA I, L.P.
    Date Received
    January 17, 2003
    Decision Date
    April 3, 2003
    Product Code
    HBE
    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
    HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

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    Other Clearances by BRASSELER USA I, L.P.

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