The following data is part of a premarket notification filed by Glidewell Laboratories-sleep Devices Group with the FDA for Thermoformed Mouthguards.
| Device ID | K121365 |
| 510k Number | K121365 |
| Device Name: | THERMOFORMED MOUTHGUARDS |
| Classification | Mouthguard, Prescription |
| Applicant | GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP 2181 DUPONT DR. Irvine, CA 92612 |
| Contact | Armin Zehtabchi |
| Correspondent | Armin Zehtabchi GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP 2181 DUPONT DR. Irvine, CA 92612 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745COMSPL0 | K121365 | 000 |