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

    SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM

    K Number: K931395 · Decision Jan 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    28
    Applicant Total
    15
    Review Days
    315

    Basic Information

    Device Name
    SERIES 5000 BATTERY POWERED INSTRUMENT SYSTEM
    K Number
    K931395
    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
    MICRO SURGICAL INSTRUMENTS CORP.
    Date Received
    March 19, 1993
    Decision Date
    January 28, 1994
    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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