EXMOOR AURAL GROMMET AG/T5

EXMOOR AURAL GROMMET AG/T5 is an FDA 510(k)-cleared medical device (K810706) manufactured by Exmoor Plastics , Ltd.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 1981. Regulation: 8.