510(k) K120600

DURAGEN SECURE DURAL REGNERATION MATRIX by Integra Life Sciences — Product Code GXQ

K120600 is an FDA 510(k) premarket notification submitted by Integra Life Sciences for the device "DURAGEN SECURE DURAL REGNERATION MATRIX". The FDA issued a decision of Substantially Equivalent on June 15, 2012. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Integra Life Sciences has at least 2 other 510(k) clearances on record.