510(k) K072296

POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 by Theragenics Corp. — Product Code KXK

K072296 is an FDA 510(k) premarket notification submitted by Theragenics Corp. for the device "POIINT OF CARE STRANDING SYSTEM, MODE 1004-00". The FDA issued a decision of Substantially Equivalent on September 26, 2007. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Theragenics Corp. has at least 4 other 510(k) clearances on record.