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

    STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT

    K Number: K972367 · Decision Sep 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    28
    Applicant Total
    74
    Review Days
    71

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    Basic Information

    Device Name
    STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
    K Number
    K972367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    June 25, 1997
    Decision Date
    September 4, 1997
    Product Code
    KIJ
    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
    KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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