RENACLEAN SH DIALYZER CLEANING SYSTEM

RENACLEAN SH DIALYZER CLEANING SYSTEM is an FDA 510(k)-cleared medical device (K033505) manufactured by Minntech 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 April 26, 2004. Regulation: 8.