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Millenium Reprocessing Services, Inc.
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AIRCAST, MODEL #3011 is an FDA 510(k)-cleared medical device (K013297) manufactured by Millenium Reprocessing Services, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 13, 2002. Regulation: 8.