EAGLE MEDICAL ANTI-FOG KIT

EAGLE MEDICAL ANTI-FOG KIT is an FDA 510(k)-cleared medical device (K933618) manufactured by Eagle Medical Intl.. 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 6, 1994. Regulation: 8.