510(k) K022635

KUSKE BREAST APPLICATOR SET, MODEL 189.006 by Nucletron Corporation — Product Code JAQ

K022635 is an FDA 510(k) premarket notification submitted by Nucletron Corporation for the device "KUSKE BREAST APPLICATOR SET, MODEL 189.006". The FDA issued a decision of Substantially Equivalent on September 6, 2002. 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.