Omeza 510(k) for Collagen Wound Matrix

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FDA has cleared an Omeza 510(k) for its Omeza Collagen Matrix for chronic wound care. The matrix comprises hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes, the company says. “When applied to a wound surface, the matrix is naturally incorporated into the wound over time,” it says, adding that it is designed for “intimate contact with both regular and irregular wound beds to provide a conducive environment for the patient's natural wound healing process.” The device is indicated for managing wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears) and draining wounds.

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