510(k) K033814

BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 by C.R. Bard, Inc. — Product Code FTL

K033814 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007". The FDA issued a decision of Substantially Equivalent on March 1, 2004. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.