510(k) K163206

SMD-Sr90-DA Radionuclide Brachytherapy Source by Salutaris Medical Devices, Inc. — Product Code KXK

K163206 is an FDA 510(k) premarket notification submitted by Salutaris Medical Devices, Inc. for the device "SMD-Sr90-DA Radionuclide Brachytherapy Source". The FDA issued a decision of Substantially Equivalent on December 15, 2016. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Salutaris Medical Devices, Inc. has at least 1 other 510(k) clearance on record.