510(k) K033828

CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

K033828 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406". The FDA issued a decision of Substantially Equivalent on February 2, 2004. 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.