510(k) K091117

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

K091117 is an FDA 510(k) premarket notification submitted by Isoaid, LLC for the device "ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA". The FDA issued a decision of Substantially Equivalent on September 15, 2009. 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.