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

    CIVCO STEPPER

    K Number: K871413 · Decision Jul 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    526
    Registration Numbers
    526
    Same Product Code
    18
    Applicant Total
    29
    Review Days
    97

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    Basic Information

    Device Name
    CIVCO STEPPER
    K Number
    K871413
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    CIVCO Medical Instruments Co., Inc.
    Date Received
    April 8, 1987
    Decision Date
    July 14, 1987
    Product Code
    FZX
    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
    FZX Guide, Surgical, Instrument

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