
Baxter Healthcare Corp
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PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 is an FDA 510(k)-cleared medical device (K980656) 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 May 18, 1998. Regulation: 8.