MEDOVATIONS ESOPHAGEAL DILATOR

MEDOVATIONS ESOPHAGEAL DILATOR is an FDA 510(k)-cleared medical device (K002363) manufactured by Medovations, 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 October 31, 2000. Regulation: 8.