CELESTIN PULSION ESOPHOGEAL PROSTHESIS

CELESTIN PULSION ESOPHOGEAL PROSTHESIS is an FDA 510(k)-cleared medical device (K813169) manufactured by Inmed 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 December 2, 1981. Regulation: 8.