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

    BUDDE-HALO RETRACTOR

    K Number: K830332 · Decision Mar 2, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    19
    Review Days
    29

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    Basic Information

    Device Name
    BUDDE-HALO RETRACTOR
    K Number
    K830332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Ohio Medical Instrument Co., Inc.
    Date Received
    February 1, 1983
    Decision Date
    March 2, 1983
    Product Code
    GZT
    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
    GZT Retractor, Self-Retaining, For Neurosurgery

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