510(k) K911329

BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE by C.R. Bard, Inc. — Product Code FOC

K911329 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE". The FDA issued a decision of Substantially Equivalent on May 28, 1991. The device falls under product code FOC (Bag, Urine Collection, Newborn), a Class II device regulated under 21 CFR 876.5250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.