MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE

MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE is an FDA 510(k)-cleared medical device (K101330) manufactured by Midwest Reprocessing Center, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2010. Regulation: 8.