510(k) K040868

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH by Genzyme Corp. — Product Code FTM

K040868 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH". The FDA issued a decision of Substantially Equivalent on June 4, 2004. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Genzyme Corp. has at least 10 other 510(k) clearances on record.