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 |