510(k) K060349

PROGUIDE NEEDLE SET by Nucletron Corporation — Product Code JAQ

K060349 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "PROGUIDE NEEDLE SET". The FDA issued a decision of Substantially Equivalent on March 10, 2006. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Nucletron Corporation has at least 10 other 510(k) clearances on record.