BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GEMINI SURGICAL LIGHT

    K Number: K880198 · Decision Feb 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    19
    Applicant Total
    36
    Review Days
    26

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    Basic Information

    Device Name
    GEMINI SURGICAL LIGHT
    K Number
    K880198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Sterilizer Co.
    Date Received
    January 15, 1988
    Decision Date
    February 10, 1988
    Product Code
    FSS
    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
    FSS Light, Surgical, Floor Standing

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