510(k) K991637

BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 by Davol Inc., Sub. C. R. Bard, Inc. — Product Code FTL

K991637 is an FDA 510(k) premarket notification submitted by Davol Inc., Sub. C. R. Bard, Inc. for the device "BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700". The FDA issued a decision of Substantially Equivalent on June 22, 1999. 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.