510(k) K011657

HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K011657 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR". The FDA issued a decision of Substantially Equivalent on August 27, 2001. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.