510(k) K082250

AURAGEN CORTICAL SURFACE ELECTRODES by Integra Neurosciences — Product Code GYC

K082250 is an FDA 510(k) premarket notification submitted by Integra Neurosciences for the device "AURAGEN CORTICAL SURFACE ELECTRODES". The FDA issued a decision of Substantially Equivalent on October 10, 2008. The device falls under product code GYC (Electrode, Cortical), a Class II device regulated under 21 CFR 882.1310. Integra Neurosciences has at least 8 other 510(k) clearances on record.