510(k) K073391

SURGISIS BIODESIGN TISSUE GRAFT by Cook Biotech, Inc. — Product Code FTM

K073391 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "SURGISIS BIODESIGN TISSUE GRAFT". The FDA issued a decision of Substantially Equivalent on March 21, 2008. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.