510(k) K945060

HERNIA MESH INTRODUCTION SYSTEM by Gerard Medical, Inc. — Product Code FTL

K945060 is an FDA 510(k) premarket notification submitted by Gerard Medical, Inc. for the device "HERNIA MESH INTRODUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 1995. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Gerard Medical, Inc. has at least 3 other 510(k) clearances on record.