Clearance Summary
ORAVAN OSA received FDA 510(k) clearance under submission number K121285, sponsored by New Jersey Snoring Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2013-03-08.
- Submission: K121285
- Applicant / Sponsor: New Jersey Snoring Solutions
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2013-03-08
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.