IRRIGATION/SUCTION HANDLE AND SHEATH

IRRIGATION/SUCTION HANDLE AND SHEATH is an FDA 510(k)-cleared medical device (K963757) manufactured by Richard Wolf Medical Instruments Corp.. 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 November 25, 1996. Regulation: 8.