510(k) K121070

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

K121070 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "C-QUR RPM MESH". The FDA issued a decision of Substantially Equivalent on April 26, 2012. 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.