ACHELASIA BALLOON DIALATOR

ACHELASIA BALLOON DIALATOR is an FDA 510(k)-cleared medical device (K884715) manufactured by Primrose Medical, 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 September 28, 1989. Regulation: 8.