BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DURAL DISSECTORS

    K Number: K910226 · Decision Feb 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    211
    Registration Numbers
    211
    Same Product Code
    33
    Applicant Total
    8
    Review Days
    25

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    Basic Information

    Device Name
    DURAL DISSECTORS
    K Number
    K910226
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.4535
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Acra Cut, Inc.
    Date Received
    January 18, 1991
    Decision Date
    February 12, 1991
    Product Code
    HAO
    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
    HAO Instrument, Surgical, Non-Powered

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