510(k) K140941

PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH by Sofradim Production — Product Code FTL

K140941 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH". The FDA issued a decision of Substantially Equivalent on May 7, 2014. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Sofradim Production has at least 10 other 510(k) clearances on record.