DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR is an FDA 510(k)-cleared medical device (K830090) manufactured by Hudson Oxygen Therapy Sales Co.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1983. Regulation: 8.