SYNTRA + DIALYZER, MODEL 200

SYNTRA + DIALYZER, MODEL 200 is an FDA 510(k)-cleared medical device (K023664) manufactured by Baxter Healthcare Corp. 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 February 20, 2003. Regulation: 8.