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

    SABLE BLADES

    K Number: K863885 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    303
    Registration Numbers
    303
    Same Product Code
    47
    Applicant Total
    1
    Review Days
    18

    Basic Information

    Device Name
    SABLE BLADES
    K Number
    K863885
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    SABLE INDUSTRIES
    Date Received
    October 6, 1986
    Decision Date
    October 24, 1986
    Product Code
    GES
    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
    GES Blade, Scalpel

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