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

    FLUORESCENT SUN LAMP FIXTURE

    K Number: K802291 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    42

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    Basic Information

    Device Name
    FLUORESCENT SUN LAMP FIXTURE
    K Number
    K802291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Strato-Ray Co.
    Date Received
    September 19, 1980
    Decision Date
    October 31, 1980
    Product Code
    HJE
    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
    HJE Lamp, Fluorescein, Ac-Powered

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