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Mimedx Group, Inc.
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HYDROFIX VASO SHIELD, MODEL HVS-001-0610 is an FDA 510(k)-cleared medical device (K101826) manufactured by Mimedx Group, 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 July 27, 2010. Regulation: 8.