510(k) K920431

OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE by Omnitron Intl., Inc. — Product Code JAQ

K920431 is an FDA 510(k) premarket notification submitted by Omnitron Intl., Inc. for the device "OMNITRON NEEDLE APPLICATORS 18 AND 21 GAUGE". The FDA issued a decision of Substantially Equivalent on May 29, 1992. 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.