
Medivance, Inc.
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ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 is an FDA 510(k)-cleared medical device (K101092) manufactured by Medivance, 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 15, 2010. Regulation: 8.