DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE is an FDA 510(k)-cleared medical device (K051487) manufactured by Doctor'S Research Group, Inc.. 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 December 21, 2005. Regulation: 8.