510(k) K953577

BARD VISILEX MESH 3 X 6 by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

K953577 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "BARD VISILEX MESH 3 X 6". The FDA issued a decision of Substantially Equivalent on September 26, 1995. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol Inc., Sub. C. R. Bard, Inc. has at least 10 other 510(k) clearances on record.