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510(k) Data Aggregation

    K Number
    K121361
    Device Name
    CURALINE POLYURETHANE FOAM AWC DRESSING
    Manufacturer
    Date Cleared
    2012-11-30

    (207 days)

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

    CURALINE INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Curaline Polyurethane Foam Dressings are intended for the management of partial and full thickness wounds; pressure ulcers (Stage I-IV); diabetic ulcers; acute and chronic venous stasis ulcers; arterial ulcers; skin grafts, donor and recipient sites; burns (1" and 2nd degree); skin tears and avulsions; abrasions; tube, catheter, and IV sites; dermatologic disorders: under compression bandages and wraps; traumatic wounds; acute and chronic wounds: and minimal, moderate, and heavily exuding wounds.
    Device Description
    The Curaline Polyurethane Foam Dressing is composed of a hydrophilic polyurethane matrix backed with a semipermeable polyurethane film which limits oxygen and moisture vapor permeability and is a barrier to liquids. The dressing contains a cleanser (F68 surfactant), a moisturizer (glycerin), and an absorbing agent (superabsorbent polymer), all in the polyurethane matrix. Both F68 and glycerin are soluble in wound fluid or skin moisture. The superabsorbent polymer contained in the dressing draws and absorbs moisture from wound fluid.
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