PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT

PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT is an FDA 510(k)-cleared medical device (K760435) manufactured by Richard'S Medical Equip., 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 26, 1976. Regulation: 8.