ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM

ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM is an FDA 510(k)-cleared medical device (K033149) manufactured by Ultimate Concepts, 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 March 22, 2004. Regulation: 8.