510(k) K955844

APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER by Varian Assoc., Inc. — Product Code JAQ

K955844 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER". The FDA issued a decision of Substantially Equivalent on July 26, 1996. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Assoc., Inc. has at least 10 other 510(k) clearances on record.