510(k) K171727

Hydrocleanse Antimicrobial Skin and Wound Care Solution by Sonoma Pharmaceuticals — Product Code FRO

K171727 is an FDA 510(k) premarket notification submitted by Sonoma Pharmaceuticals for the device "Hydrocleanse Antimicrobial Skin and Wound Care Solution". The FDA issued a decision of Substantially Equivalent on July 26, 2017. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sonoma Pharmaceuticals has at least 7 other 510(k) clearances on record.