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Olympus Terumo Biomaterials Corporation
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OSFERION is an FDA 510(k)-cleared medical device (K080065) manufactured by Olympus Terumo Biomaterials Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2008. Regulation: 8.