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Medtronic, Inc.
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HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) is an FDA 510(k)-cleared medical device (K111339) manufactured by Medtronic, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2011. Regulation: 8.