510(k) K161395

SPEC Model M13 by Source Production and Equipment Co., Inc. — Product Code KXK

K161395 is an FDA 510(k) premarket notification submitted by Source Production and Equipment Co., Inc. for the device "SPEC Model M13". The FDA issued a decision of Substantially Equivalent on July 6, 2016. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Source Production and Equipment Co., Inc. has at least 6 other 510(k) clearances on record.