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

    REMINGTON TANFASTIC HANDHELD TANNING WAND

    K Number: K895410 · Decision Nov 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    3
    Review Days
    82

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    Basic Information

    Device Name
    REMINGTON TANFASTIC HANDHELD TANNING WAND
    K Number
    K895410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Remington Products Company, LLC
    Date Received
    September 6, 1989
    Decision Date
    November 27, 1989
    Product Code
    FTC
    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
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by Remington Products Company, LLC

    K Number Device Name
    K013328 REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
    K895409 REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER