MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT

MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT is an FDA 510(k)-cleared medical device (K872710) manufactured by Directed Energy, 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 September 23, 1987. Regulation: 8.