
Estracorporeal, Inc.
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COIL DIALYSIS, MODELS DM-360 AND DM-360- is an FDA 510(k)-cleared medical device (K790382) manufactured by Estracorporeal, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 1979. Regulation: 8.