510(k) K881665

OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR by Omnitron Intl., Inc. — Product Code JAQ

K881665 is an FDA 510(k) premarket notification submitted by Omnitron Intl., Inc. for the device "OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR". The FDA issued a decision of Substantially Equivalent on August 11, 1988. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Omnitron Intl., Inc. has at least 6 other 510(k) clearances on record.