510(k) K113210

ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT by Isoaid, LLC — Product Code KXK

K113210 is an FDA 510(k) premarket notification submitted by Isoaid, LLC for the device "ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT". The FDA issued a decision of Substantially Equivalent on August 10, 2012. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Isoaid, LLC has at least 5 other 510(k) clearances on record.