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Dideco S.P.A.
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APEX ADULT HOLLOWE FIBER OXYGENATOR is an FDA 510(k)-cleared medical device (K014080) manufactured by Dideco S.P.A.. 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 7, 2002. Regulation: 8.