THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 is an FDA 510(k)-cleared medical device (K043596) manufactured by Theragenics Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2005. Regulation: 8.