The following data is part of a premarket notification filed by American Dental Sleep Medicine, Ip, Llc with the FDA for Medley Gold.
| Device ID | K140435 |
| 510k Number | K140435 |
| Device Name: | MEDLEY GOLD |
| Classification | Device, Anti-snoring |
| Applicant | AMERICAN DENTAL SLEEP MEDICINE, IP, LLC 219 RIDGEVIEW DRIVE Wexford, PA 15090 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AMERICAN DENTAL SLEEP MEDICINE, IP, LLC 219 RIDGEVIEW DRIVE Wexford, PA 15090 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-06-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEDLEY GOLD 86023041 4611056 Live/Registered |
American Dental Sleep Medicine, IP, LLC 2013-07-30 |