510(k) K081010

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

K081010 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "BARD 3DMAX MESH". The FDA issued a decision of Substantially Equivalent on October 7, 2008. 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.