510(k) K111313

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE by Alcavis Hdc, LLC — Product Code FQH

K111313 is an FDA 510(k) premarket notification submitted by Alcavis Hdc, LLC for the device "EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475.