510(k) K082858

EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER by Alcavis International, Inc. — Product Code FQH

K082858 is an FDA 510(k) premarket notification submitted by Alcavis International, Inc. for the device "EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER". The FDA issued a decision of Substantially Equivalent on May 27, 2009. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Alcavis International, Inc. has at least 2 other 510(k) clearances on record.