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510(k) Data Aggregation

    K Number
    K111382
    Device Name
    CELVER
    Date Cleared
    2012-05-31

    (380 days)

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

    CELLULOSE CONCEPTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1st degree burns. For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
    Device Description
    CELVER® is a sterile silver moist wound dressing. CELVER® is composed of sodium carboxymethylcellulose, sodium lactate and ionic silver imbedded into a non-woven 100% cotton substrate. In contact with wound exudate, the highly adsorbent dressing creates a soft cohesive gel that forms an intimate contact with the wound surface and maintains a moist wound-healing environment. The construction of the bandage provides for easy removal with minimal residue left on the wound. The bandage dimensions are 4" x 4" and is further perforated into 15 equal sections appropriately ¾" x 1 ½" for flexibility and ease of use.
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