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Sorin Group Deutschland GmbH
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SORIN C5 SYSTEM MODEL 58-00-00 is an FDA 510(k)-cleared medical device (K093882) manufactured by Sorin Group Deutschland GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 14, 2010. Regulation: 8.