510(k) K101462

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH by Caldera Medical, Inc. — Product Code FTL

K101462 is an FDA 510(k) premarket notification submitted by Caldera Medical, Inc. for the device "ASCEND BLUE AC MESH; ASCEND BLUE PC MESH". The FDA issued a decision of Substantially Equivalent on August 16, 2010. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Caldera Medical, Inc. has at least 10 other 510(k) clearances on record.