Clearance Summary
FULL BREATH SLEEP APPLIANCE LOWER (FBSL) received FDA 510(k) clearance under submission number K091035, sponsored by Bryan Keropian Dds. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-06-24.
- Submission: K091035
- Applicant / Sponsor: Bryan Keropian Dds
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2009-06-24
Classification & Regulation
This clearance is catalogued under FDA product code LQZ and 21 CFR 872.5570, within the Dental review panel as a Class II device.