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Collins Medical, Inc.
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GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 is an FDA 510(k)-cleared medical device (K030917) manufactured by Collins Medical, 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 May 13, 2003. Regulation: 8.