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510(k) Data Aggregation

    K Number
    K130599
    Device Name
    WART FREEZE
    Manufacturer
    KONINKLIJKE UTERMOHLEN NV
    Date Cleared
    2013-06-05

    (90 days)

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

    KONINKLIJKE UTERMOHLEN NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is indicated for the removal of common and plantar warts. The product is indicated for the removal of common and plantar warts.
    Device Description
    Wart Freeze is a private label (private label trade mark: Wart Freezer, Cryogenic Wart Remover) over the counter cryosurgery product for the treatment of common and plantar warts. The device consists of the following: - A pressurised dispenser (canister) containing as ingredient 38ml dimethylether (DME) with a . polypropylene applicator that is permanently attached (fixed) to the dispenser. The gas does not harm the ozone layer. The applicator is used to administer the cryogen directly to the wart. The applicator is cleaned after each use. - Disposable 70% alcohol cleansing swabs for cleaning the applicator after each use . - Instruction for use . The Wart Freeze (private label trade mark: Wart Freezer, Cryogenic Wart Remover) is a 21. cryosurgical system comprised of a dispenser containing as ingredient, dimethylether (DME), and a permanently attached (fixed) applicator to apply the cryogen directly to the wart.
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    K Number
    K101049
    Device Name
    WART FREEZE
    Manufacturer
    KONINKLIJKE UTERMOHLEN NV
    Date Cleared
    2011-06-23

    (435 days)

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

    KONINKLIJKE UTERMOHLEN NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wart Freeze is indicated for the removal of common and plantar warts.
    Device Description
    Wart Freeze is an over the counter cryosurgical product to remove common and plantar warts. The device consists of the following: Pressurized canister with the cryogen liquid dimethyl ether (DME), a dose valve which expels a specific quantity of the cryogen onto the wart, a polypropylene reusable applicator, 70% alcohol disposable cleansing swabs, Protective plasters (bandages).
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