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510(k) Data Aggregation
K Number
K070463Device Name
REVERA WOUND CARE, MODEL MDW0060
Manufacturer
REVALESIO CORPORATION
Date Cleared
2008-05-07
(446 days)
Product Code
FRO, KMF, MUG
Regulation Number
N/AWhy 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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