510(k) K980601

VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER by Varian Assoc., Inc. — Product Code JAQ

K980601 is an FDA 510(k) premarket notification submitted by Varian Assoc., Inc. for the device "VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADER". The FDA issued a decision of Substantially Equivalent on October 21, 1998. 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.