GALILEO DISPOSABLE ENDOSCOPES

GALILEO DISPOSABLE ENDOSCOPES is an FDA 510(k)-cleared medical device (K981928) manufactured by Galileo Electro-Optics 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 August 5, 1998. Regulation: 8.