510(k) K904779

BUTTON REPLACEMENT GASTROSTOMY DEVICE by C.R. Bard, Inc. — Product Code KGC

K904779 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BUTTON REPLACEMENT GASTROSTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on January 18, 1991. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.