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

    HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST

    K Number: K864929 · Decision Jan 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    387
    Registration Numbers
    387
    Same Product Code
    75
    Applicant Total
    8
    Review Days
    43

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    Basic Information

    Device Name
    HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
    K Number
    K864929
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hall Surgical, Division of Zimmer, Inc.
    Date Received
    December 16, 1986
    Decision Date
    January 28, 1987
    Product Code
    HWE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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    Other Clearances by Hall Surgical, Division of Zimmer, Inc.

    K Number Device Name
    K942660 HALL MICROCHOICE ELECTRIC POWERED SYSTEM
    K864734 HALL ORAL IMPLANT SYSTEM
    K864163 HALL DUNBAR DRILL GUIDE SYSTEM
    K862778 HALL CANNLULA SYSTEM
    K862474 HALL STERNUM SAW
    K862529 HALL STERILE BUR
    K852143 HALL IRRIGATION SYSTEM