IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER

IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER is an FDA 510(k)-cleared medical device (K923939) manufactured by American Healthcare 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 June 16, 1993. Regulation: 8.