ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

ANGEL OF WATER COLON HYDROTHERAPY SYSTEM is an FDA 510(k)-cleared medical device (K003720) manufactured by Lifestream Purfication Systems, LLC. 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 June 26, 2002. Regulation: 8.