510(k) K091142

TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 by Rti Biologics, Inc. — Product Code FTM

K091142 is an FDA 510(k) premarket notification submitted by Rti Biologics, Inc. for the device "TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358". The FDA issued a decision of Substantially Equivalent on Aug 31, 2009. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Rti Biologics, Inc. has 2 other 510(k) clearances on record.