510(k) K090848

PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM by Premier Brands of America, Inc. — Product Code FQH

K090848 is an FDA 510(k) premarket notification submitted by Premier Brands of America, Inc. for the device "PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM". The FDA issued a decision of Substantially Equivalent on June 17, 2009. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475.