510(k) K050311

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

K050311 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM MEDICAL CORPORATION C-QUR MESH". The FDA issued a decision of Substantially Equivalent on March 31, 2006. 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.