510(k) K100076

ATRIUM C-QUR OVT MESH by Atrium Medical Corp. — Product Code FTL

K100076 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM C-QUR OVT MESH". The FDA issued a decision of Substantially Equivalent on January 26, 2010. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.