510(k) K092534

ALATUS VAGINAL BALLOON PACKING SYSTEM by Radiadyne — Product Code JAQ

K092534 is an FDA 510(k) premarket notification submitted by Radiadyne for the device "ALATUS VAGINAL BALLOON PACKING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 7, 2009. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Radiadyne has at least 4 other 510(k) clearances on record.