510(k) K131015

BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT by Cook Biotech, Inc. — Product Code GXQ

K131015 is an FDA 510(k) premarket notification submitted by Cook Biotech, Inc. for the device "BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT". The FDA issued a decision of Substantially Equivalent on October 8, 2013. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Cook Biotech, Inc. has at least 10 other 510(k) clearances on record.