BULB IRRIGATION TRAY

BULB IRRIGATION TRAY is an FDA 510(k)-cleared medical device (K900736) manufactured by Orion Life Systems, 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 April 16, 1990. Regulation: 8.