BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    ULTRA TAN PURPLE PRO

    K Number: K875190 · Decision Jan 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    ULTRA TAN PURPLE PRO
    K Number
    K875190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ultra Tan Intl. AB
    Date Received
    December 17, 1987
    Decision Date
    January 14, 1988
    Product Code
    LEJ
    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
    LEJ Booth, Sun Tan

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    Other Clearances by Ultra Tan Intl. AB

    K Number Device Name
    K875189 ULTRA TAN PURPLE MINT