510(k) K041140

ACELL UBM SURGICAL MESH ML AND MLPLUS by Acell, Inc. — Product Code FTM

K041140 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "ACELL UBM SURGICAL MESH ML AND MLPLUS". The FDA issued a decision of Substantially Equivalent on July 7, 2004. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Acell, Inc. has at least 10 other 510(k) clearances on record.