510(k) K080779

IRRISEPT WOUND CLEANSING SYSTEM by Irrimax Corporation — Product Code FQH

K080779 is an FDA 510(k) premarket notification submitted by Irrimax Corporation for the device "IRRISEPT WOUND CLEANSING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 2009. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Irrimax Corporation has at least 4 other 510(k) clearances on record.