
Theragenics Corp.
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THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 is an FDA 510(k)-cleared medical device (K010283) 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 April 25, 2001. Regulation: 8.