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International Brachytherapy S.A.
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OPTISOURCE, MODEL 1032P is an FDA 510(k)-cleared medical device (K040766) manufactured by International Brachytherapy S.A.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 2004. Regulation: 8.