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510(k) Data Aggregation

    K Number
    K080010
    Device Name
    NOCC HYDROPHILIC WOUND DRESSING
    Manufacturer
    KYTOGENICS, INC
    Date Cleared
    2008-03-14

    (71 days)

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

    KYTOGENICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree burns.
    Device Description
    NOCC™ (N,O-Carboxymethylchitosan) Hydrophilic Wound Dressing is a hydrogel that provides a moist wound environment to support wound healing. The gel is clear which aids in visualization of the wound.
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