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510(k) Data Aggregation

    K Number
    K211972
    Device Name
    Omeza Collagen Matrix
    Manufacturer
    Date Cleared
    2021-09-01

    (69 days)

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

    Omeza, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Omeza® Collagen Matrix is indicated for the management of 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, podiatric, wound dehiscence) - · Trauma wounds (abrasions, lacerations, superficial thickness burns, skin tears) - · Draining wounds The device is intended for one-time use.
    Device Description
    Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular wound beds to providea conducive environment for the patient's natural wound healing process.
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