The following data is part of a premarket notification filed by The Center For Craniofacial & Dental Sleep Medicine with the FDA for Meridian Pm.
| Device ID | K170053 |
| 510k Number | K170053 |
| Device Name: | Meridian PM |
| Classification | Device, Anti-snoring |
| Applicant | The Center For Craniofacial & Dental Sleep Medicine 4545 Sweetwater Blvd Sugarland, TX 77479 |
| Contact | Samuel Cress |
| Correspondent | Cheryl Fisher FisherMed Consulting LLC 260 Howard Drive Santa Clara, CA 95051 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-05 |
| Decision Date | 2017-11-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MERIDIAN PM 87718034 5523975 Live/Registered |
CFDSM, LLC 2017-12-12 |