510(k) K061314

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

K061314 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH". The FDA issued a decision of Substantially Equivalent on June 2, 2006. 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.