VARIAN ESOPHAGUS BOUGIE APPLICATOR

VARIAN ESOPHAGUS BOUGIE APPLICATOR is an FDA 510(k)-cleared medical device (K063815) manufactured by Varian Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 2007. Regulation: 8.