510(k) K041038

CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER by Churchill Medical Systems, Inc. — Product Code KPE

K041038 is an FDA 510(k) premarket notification submitted by Churchill Medical Systems, Inc. for the device "CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Churchill Medical Systems, Inc. has at least 10 other 510(k) clearances on record.