510(k) K003323

COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 by Davol, Inc. — Product Code FTL

K003323 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205". The FDA issued a decision of Substantially Equivalent on January 22, 2001. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Davol, Inc. has at least 10 other 510(k) clearances on record.