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510(k) Data Aggregation

    K Number
    K101118
    Device Name
    ACTIVON TULLE
    Date Cleared
    2010-12-15

    (238 days)

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

    CALIDAD SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OTC: For minor wounds, ulcerations and burns, abraded skin, and irritated areas. Professional: Intended in the management of: - diabetic foot ulcers; - leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); - pressure ulcers/sores (partial and full thickness); - 1st and 2nd degree partial thickness burns; - grafted and donor sites and traumatic and surgical wounds.
    Device Description
    Activon Tulle is a sterile wound care dressing for use in moist wound management. Activon Tulle is offered as 2x2 inch and 4x4 inch non-adherent knitted viscose primary dressing impregnated with 100% Manuka honey for effective wound treatment.
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