The following data is part of a premarket notification filed by Migratherapy Llc with the FDA for Migra Tab, Quicksplint Migraine.
| Device ID | K111066 |
| 510k Number | K111066 |
| Device Name: | MIGRA TAB, QUICKSPLINT MIGRAINE |
| Classification | Mouthguard, Prescription |
| Applicant | MIGRATHERAPY LLC 4403 MANCHESTER AVENUE, SUITE 103 Encinitas, CA 92024 |
| Contact | Bradley Eli |
| Correspondent | Bradley Eli MIGRATHERAPY LLC 4403 MANCHESTER AVENUE, SUITE 103 Encinitas, CA 92024 |
| 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 | 2011-04-18 |
| Decision Date | 2011-11-22 |
| Summary: | summary |