
Extracorporeal Medical Specialities, Inc.
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BICARBONATE/VARIABLE SODIUM KIT-DM-367 is an FDA 510(k)-cleared medical device (K830908) manufactured by Extracorporeal Medical Specialities, 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 June 7, 1983. Regulation: 8.