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510(k) Data Aggregation

    K Number
    K051542
    Device Name
    TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
    Manufacturer
    Date Cleared
    2006-03-17

    (280 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIOSYN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Triosyn T40™ Antimicrobial Dressing is designed for use in partial and full thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. The Triosyn T40™ Antimicrobial Dressing may be used over debrided and grafted partial thickness wounds.
    Device Description
    The Triosyn T40'''' Antimicrobial Wound Dressing is a sterile, primary wound dressing. It is a multi-layer composite dressing consisting of an absorbent polycster non-woven pad, a permeable adhesive, a single layer of Triosyn iodinated resin beads, and a non-adherent high-density polyethylene mesh (HDPE). This non-adhesive composite dressing is designed to be used as a barrier against microbial penetrations and as a method to reduce the microbial load in partial and full thickness wounds'.
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