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510(k) Data Aggregation

    K Number
    K121898
    Device Name
    STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
    Manufacturer
    QUICK-MED TECHNOLOGIES, INC.
    Date Cleared
    2013-05-24

    (329 days)

    Product Code
    FRL
    Regulation Number
    880.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUICK-MED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stay Fresh Skin Fold Management Textile is a skin protectant intended to be used between skin folds and in other skin contact areas to provide moisture management and reduce friction. The Stay Fresh Skin Fold Management Textile contains hydrogen peroxide, which reduces bacterial populations in the fabric.
    Device Description
    Stav Fresh Skin Fold Management Textile is a non-sterile skin protectant indicated for management of skin folds and other skin-to-skin contact areas, such as extremities, and is offered as a 25.4 cm x 365.8 cm fabric piece (other sizes may also be available). The device provides moisture management to keep skin dry and the device's low coefficient of friction reduces skin-to-skin friction. Stay Fresh Skin Fold Management Textile is a single patient use product that is custom cut from a multiuse package. Polyester fabrics are well known to wick moisture away from skin as well as provide a low friction surface.
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    K Number
    DEN070002
    Device Name
    QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
    Manufacturer
    QUICK-MED TECHNOLOGIES, INC.
    Date Cleared
    2009-02-25

    (657 days)

    Product Code
    NYS
    Regulation Number
    878.4015
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUICK-MED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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