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510(k) Data Aggregation

    K Number
    K143124
    Device Name
    KA01 Chitosan Wound Dressing
    Manufacturer
    FOSHAN UNITED MEDICAL TECHNOLOGIES LTD.
    Date Cleared
    2015-01-26

    (87 days)

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

    FOSHAN UNITED MEDICAL TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx: The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of: - Pressure sores - Diabetic ulcers - Leg ulcers - Donor sites and graft sites - Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns - Trauma wounds OTC: The KA01 Chitosan Wound Dressing may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - Abrasions - Lacerations
    Device Description
    The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal. The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a variety of chronic and acute wounds. It is intended to be secured with a semi permeable adhesive secondary dressing and to remain in place up to 7 days depending on the level of exudate. Dressings are individually packed in paper/poly pouches and terminally sterilized to achieve a SAL 106. A range of dressing sizes between 25cm2 and 220cm2 is available.
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