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510(k) Data Aggregation

    K Number
    K152544
    Device Name
    Agem Ag Mesh Dressing with Silver
    Date Cleared
    2016-05-23

    (262 days)

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

    SHENZHEN YUANXING NANO-PHARMA CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under the supervision of a health care professional, this dressing may be used as a primary wound dressing over: - abrasions - ulcers - trauma wounds - · surgical wounds - · first and second degree burns - donor sites This product is not designed, sold or intended for use except as indicated.
    Device Description
    Agem® Ag Mesh Dressing with Silver is a nonwoven dressing that contains (8mg/gm of dressing) of silver sulfate. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base. The dressing creates an effective barrier and silver ions from the silver sulfate have been demonstrated in vitro to reduce the number of bacteria and yeast in the dressing.
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