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

    SEMI-OVAL MODULAR SUNTANNING BOOTH

    K Number: K802756 · Decision Jan 22, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    7
    Review Days
    78

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    Basic Information

    Device Name
    SEMI-OVAL MODULAR SUNTANNING BOOTH
    K Number
    K802756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tannhut
    Date Received
    November 5, 1980
    Decision Date
    January 22, 1981
    Product Code
    LEJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    RA
    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 Tannhut

    K Number Device Name
    K851859 FACIAL/UPPER BODY UNIT
    K851858 FOLD AWAY HUT
    K851255 SUN BEDS
    K840137 SILGMANN SOLARIUM S-TYPE 1218 COMBO
    K837283 UNKNOWN
    K812579 SUNTANNING HOME UNIT