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

    EASYSUITE SURGICAL LIGHT CONTROL (ESLC)

    K Number: K102791 · Decision Nov 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
    K Number
    K102791
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Image Stream Medical, Inc.
    Date Received
    September 27, 2010
    Decision Date
    November 23, 2010
    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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