
Astral Medical Systems
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COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE is an FDA 510(k)-cleared medical device (K851153) manufactured by Astral Medical Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1985. Regulation: 8.