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Boston Scientific Corporation
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CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 is an FDA 510(k)-cleared medical device (K100663) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 2010. Regulation: 8.