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 |