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

    HALL IRRIGATION SYSTEM

    K Number: K852143 · Decision Jun 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    8
    Review Days
    41

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    Basic Information

    Device Name
    HALL IRRIGATION SYSTEM
    K Number
    K852143
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hall Surgical, Division of Zimmer, Inc.
    Date Received
    May 16, 1985
    Decision Date
    June 26, 1985
    Product Code
    GBX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBX Catheter, Irrigation

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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
    K864929 HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
    K864163 HALL DUNBAR DRILL GUIDE SYSTEM
    K862778 HALL CANNLULA SYSTEM
    K862474 HALL STERNUM SAW
    K862529 HALL STERILE BUR