510(k) K060984

XENFORM SOFT TISSUE REPAIR MATRIX by Tei Biosciences, Inc. — Product Code FTM

K060984 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "XENFORM SOFT TISSUE REPAIR MATRIX". The FDA issued a decision of Substantially Equivalent on May 17, 2006. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.