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Gaymar Industries, Inc.
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MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 is an FDA 510(k)-cleared medical device (K100585) manufactured by Gaymar Industries, 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 January 19, 2011. Regulation: 8.