510(k) K073538

DUAL CHAMBER TPN CONTAINER by B.Braun Medical, Inc. — Product Code KPE

K073538 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "DUAL CHAMBER TPN CONTAINER". The FDA issued a decision of Substantially Equivalent on March 12, 2008. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.