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    K Number
    K151309
    Device Name
    Wartie Advanced Wart Remover or other proprietary name
    Manufacturer
    YOUMEDICAL CORP BV
    Date Cleared
    2015-08-14

    (88 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    YOUMEDICAL CORP BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wartie® Advanced Wart Remover is indicated for the over-the-counter treatment of common warts for patients ages 12 years and older.
    Device Description
    The Wartie® Advanced Wart Remover is an over the counter cryosurgery product (for the treatment of warts), to be used at home. The device consists of: - A pressurized canister filled with 50mL of the compressed liquid gas dimethyl ether with a custom application unit used to administer the cold delivered by the cryogen to the wart. - One 3 mL tube of conductive gel (also called gel). - Six disposable comfort pads. - Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
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