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Glytec, LLC (Formally Known AS Glucotec, Inc.)
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G+ SYSTEM is an FDA 510(k)-cleared medical device (K101344) manufactured by Glytec, LLC (Formally Known AS Glucotec, Inc.). This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2010. Regulation: 8.