MAGNUM FLOW IRRIGATION SYSTEM

MAGNUM FLOW IRRIGATION SYSTEM is an FDA 510(k)-cleared medical device (K010519) manufactured by Scion Valley, 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 May 13, 2001. Regulation: 8.