FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

FULL BREATH SLEEP APPLIANCE LOWER (FBSL) is an FDA 510(k)-cleared medical device (K091035) manufactured by Bryan Keropian Dds. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 23, 2009. Regulation: 8.