EXMOOR AURAL GROMMET AG/TI

EXMOOR AURAL GROMMET AG/TI is an FDA 510(k)-cleared medical device (K812459) 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 September 24, 1981. Regulation: 8.