Clearance Summary
Meridian PM received FDA 510(k) clearance under submission number K170053, sponsored by The Center For Craniofacial & Dental Sleep Medicine. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2017-11-28.
- Submission: K170053
- Applicant / Sponsor: The Center For Craniofacial & Dental Sleep Medicine
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2017-11-28
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.