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Predicate Vashe Wound Therapy System (including Vashe* Wound Therapy* Solution); PuniCore Inc. Devices K100918, August gth, 2010. Modified Device Vashe* Wound Therapy Solution is a wound cleanser solution that contains hypdchlorous.
These indications are identical to the predicate device Vasheo Wound Therapy System. (including Vashe* Wound Therapy* Solution), K100918. Summary of Vasheo Wound Therapy Solution similar to Vashe- Wound Therapy System (including Vashe. Technological Wound Therapy* Solution), K100918, includes among its labeled uses the cleansing, Characteristics irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV.