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510(k) Data Aggregation
K Number
K121361Device Name
CURALINE POLYURETHANE FOAM AWC DRESSING
Manufacturer
Date Cleared
2012-11-30
(207 days)
Product Code
Regulation Number
N/AWhy 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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