510(k) K081882

MODIFICATION TO XYLOS SURGICAL MESH by Xylos Corporation — Product Code FTM

K081882 is an FDA 510(k) premarket notification submitted by Xylos Corporation for the device "MODIFICATION TO XYLOS SURGICAL MESH". The FDA issued a decision of Substantially Equivalent on July 11, 2008. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Xylos Corporation has at least 8 other 510(k) clearances on record.