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510(k) Data Aggregation

    K Number
    K070463
    Device Name
    REVERA WOUND CARE, MODEL MDW0060
    Manufacturer
    REVALESIO CORPORATION
    Date Cleared
    2008-05-07

    (446 days)

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

    REVALESIO CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    REVERA™ Wound Care is indicated for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin, in addition to moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions, and minor burns.
    Device Description
    REVERA™ Wound Care, is a single use saline topical wound wash, that will be supplied in a 60 ml (2 oz) pouch. The mechanical action of the solution moving across the wound aids in the removal of foreign objects e.g. dirt and debris. No preservatives or stabilizers are added. REVERA™ Wound Care passes the USP <71> sterility test.
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