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

    MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)

    K Number: K081698 · Decision Jul 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    43

    Basic Information

    Device Name
    MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
    K Number
    K081698
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    IMAGE STREAM MEDICAL, INC.
    Date Received
    June 17, 2008
    Decision Date
    July 30, 2008
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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