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

    SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM

    K Number: K962789 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    40
    Applicant Total
    18
    Review Days
    28

    Basic Information

    Device Name
    SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
    K Number
    K962789
    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
    SMITH & NEPHEW ENDOSCOPY, INC.
    Date Received
    July 17, 1996
    Decision Date
    August 14, 1996
    Product Code
    GEY
    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
    GEY Motor, Surgical Instrument, Ac-Powered

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