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510(k) Data Aggregation

    K Number
    K182010
    Device Name
    ProgenaMatrix
    Manufacturer
    Cell Constructs I, LLC
    Date Cleared
    2019-01-17

    (174 days)

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

    Cell Constructs I, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ProgenaMatrix™ is indicated for dry and exuding partial and full thickness wounds such as: pressure (stage I-IV) and venous stasis ulcers caused by mixed vascular etiologies, diabetic ulcers, donor sites and grafts, first and second degree burns, superficial injuries, cuts, abrasions and surgical wounds. ProgenaMatrix™ is not intended to be used on third degree burns.
    Device Description
    ProgenaMatrix™ is a clear keratin matrix derived from human hair designed to assist wound healing by facilitating a moist wound healing environment. It is packaged in a sterile, moisture-proof, peel-open pouch containing water and propylene glycol.
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