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

    PS MEDICAL CRANIAL HAND DRILL

    K Number: K904283 · Decision Oct 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    16
    Applicant Total
    40
    Review Days
    16

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    Basic Information

    Device Name
    PS MEDICAL CRANIAL HAND DRILL
    K Number
    K904283
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Pudenz-Schulte Medical Research Corp.
    Date Received
    September 17, 1990
    Decision Date
    October 3, 1990
    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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