510(k) K082264

CONTURA LUMEN MARKER by Senorx, Inc. — Product Code JAQ

K082264 is an FDA 510(k) premarket notification submitted by Senorx, Inc. for the device "CONTURA LUMEN MARKER". The FDA issued a decision of SESU on September 12, 2008. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Senorx, Inc. has at least 10 other 510(k) clearances on record.