
Mallinckrodt Inc., Liebel-Flarsheim Business
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OPTISTAR ELITE INJECTION SYSTEM is an FDA 510(k)-cleared medical device (K073592) 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 May 6, 2008. Regulation: 8.