510(k) K063530

ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP by I-Flow Corp. — Product Code MEB

K063530 is an FDA 510(k) premarket notification submitted by I-Flow Corp. for the device "ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP". The FDA issued a decision of Substantially Equivalent on January 26, 2007. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. I-Flow Corp. has at least 10 other 510(k) clearances on record.