510(k) K043427

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

K043427 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "DURAGEN II DURAL REGENERATION MATRIX". The FDA issued a decision of Substantially Equivalent on January 12, 2005. 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.