2008 HEMODIALYSIS SORBENT SYSTEM

2008 HEMODIALYSIS SORBENT SYSTEM is an FDA 510(k)-cleared medical device (K093362) manufactured by Renal Solutions, 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 August 12, 2010. Regulation: 8.