510(k) K061228

FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR by Bryan Keropian Dds — Product Code LQZ

K061228 is an FDA 510(k) premarket notification submitted by Bryan Keropian Dds for the device "FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR". The FDA issued a decision of Substantially Equivalent on May 26, 2006. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570. Bryan Keropian Dds has at least 3 other 510(k) clearances on record.