510(k) K033936

BARD ELIMINATOR PET BALLOON DILATORS by C.R. Bard, Inc. — Product Code KNQ

K033936 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD ELIMINATOR PET BALLOON DILATORS". The FDA issued a decision of Substantially Equivalent on January 14, 2004. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.