BENTLEY-TRANTEC DISPOS. DOMES D-260-

BENTLEY-TRANTEC DISPOS. DOMES D-260- is an FDA 510(k)-cleared medical device (K841811) manufactured by American Bentley. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 1985. Regulation: 8.