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

    SILICONE INSTRUMENT SHODS

    K Number: K895591 · Decision Oct 20, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    270
    Registration Numbers
    270
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    SILICONE INSTRUMENT SHODS
    K Number
    K895591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Key Surgical, Inc.
    Date Received
    September 15, 1989
    Decision Date
    October 20, 1989
    Product Code
    GDJ
    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
    GDJ Clamp, Surgical, General & Plastic Surgery

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