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510(k) Data Aggregation

    K Number
    K120059
    Device Name
    LIQUID BANDAGE
    Manufacturer
    CHESSON LABORATORY ASSOCIATES, INC.
    Date Cleared
    2012-05-17

    (129 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESSON LABORATORY ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    [The device] is indicated for managing signs and symptoms of nail dystrophy, i.e., nail splitting and nail fragility, for intact or damaged nails. [The device] coats and adheres to the nail surface preventing direct abrasion and friction on the nail surface while also providing protection against the effects of moisture.
    Device Description
    This product for nail dystrophy is a biocompatible, polymeric lacquer that is applied directly to the nail. The product is dispersed in a solution that dries rapidly, adhering to the contours of the nail to form a transparent, colorless, flexible, waterproof barrier.
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    K Number
    K083913
    Device Name
    CHESSON LABS LIQUID BANDAGE
    Manufacturer
    CHESSON LABORATORY ASSOCIATES, INC.
    Date Cleared
    2009-07-31

    (213 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHESSON LABORATORY ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To cover intact skin or minor cuts, scrapes, burns, and irritations of the skin, to help keep them clean and dry and help protect them from infection
    Device Description
    This product is a liguid polymer in a spray format. The solution is topically applied to the affected area and the carrier solvent evaporates allowing polymerization of the remaining constituents to form a non-toxic, hydrophobic, elastomeric polymer coating that provides a barner against moisture but that is permeable to oxygen. The intended use is as a liquid bandage, as this coating is biocompatible and forms a tough yet pliable seal, preventing it from cracking and peeling as the skin heals.
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