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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.
Date Prepared: July 7h, 2010. This summary. of 5 10(k) safety and effectiveness information is being submitted in accordance with. the requirements of 21 C.F.R. Â§807.92. The assigned 5 10(k) number is :K100918. Device Name (proprietary): VasheÂ®,Wound Therapy System (including VasheÂ® Wound. Therapy ~ Solution) Common Name: Wound Cleanser.