510(k) K063648

SURGI-WRAP MAST TENDON SHEET by Mast Biosurgery USA, Inc. — Product Code FTL

K063648 is an FDA 510(k) premarket notification submitted by Mast Biosurgery USA, Inc. for the device "SURGI-WRAP MAST TENDON SHEET". The FDA issued a decision of Substantially Equivalent on March 7, 2007. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Mast Biosurgery USA, Inc. has at least 3 other 510(k) clearances on record.