510(k) K072207

DURAGEN XS DURAL REGENERATION MATRIX by Integra Lifesciences Corp. — Product Code GXQ

K072207 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "DURAGEN XS DURAL REGENERATION MATRIX". The FDA issued a decision of Substantially Equivalent on August 23, 2007. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.