510(k) K001287

EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML by Sorenson Medical, Inc. — Product Code KPE

K001287 is an FDA 510(k) premarket notification submitted by Sorenson Medical, Inc. for the device "EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML". The FDA issued a decision of Substantially Equivalent on June 9, 2000. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Sorenson Medical, Inc. has at least 5 other 510(k) clearances on record.