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Cincinnati Sub-Zero Products, Inc.
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BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS is an FDA 510(k)-cleared medical device (K101589) manufactured by Cincinnati Sub-Zero Products, 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 September 19, 2010. Regulation: 8.