SORB+HISORB+CARTRIDGE

SORB+HISORB+CARTRIDGE is an FDA 510(k)-cleared medical device (K031099) 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 September 16, 2003. Regulation: 8.