510(k) K043191

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH by Angiologica B. M. Srl — Product Code FTL

K043191 is an FDA 510(k) premarket notification submitted by Angiologica B. M. Srl for the device "REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH". The FDA issued a decision of Substantially Equivalent on May 16, 2005. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Angiologica B. M. Srl has at least 1 other 510(k) clearance on record.