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Mallinckrodt Inc., Liebel-Flarsheim Business
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OPTIBOLUS is an FDA 510(k)-cleared medical device (K031339) manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 10, 2003. Regulation: 8.