510(k) K170053
K170053 is an FDA 510(k) premarket notification submitted by The Center For Craniofacial & Dental Sleep Medicine for the device "Meridian PM". The FDA issued a decision of Substantially Equivalent on Nov 28, 2017. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 28, 2017
- Date Received
- Jan 5, 2017
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)