510(k) K991363

30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU by Sorenson Medical, Inc. — Product Code FRN

K991363 is an FDA 510(k) premarket notification submitted by Sorenson Medical, Inc. for the device "30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU". The FDA issued a decision of Substantially Equivalent on May 13, 1999. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sorenson Medical, Inc. has at least 5 other 510(k) clearances on record.