4200 PNEUMATIC MOUTH SHUTTER

4200 PNEUMATIC MOUTH SHUTTER is an FDA 510(k)-cleared medical device (K791705) manufactured by Hans Rudolph, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 3, 1979. Regulation: 8.