The following data is part of a premarket notification filed by Luco Hybrid Osa Appliance Inc. with the FDA for The Luco Hybrid Osa Appliance.
| Device ID | K160477 |
| 510k Number | K160477 |
| Device Name: | The Luco Hybrid OSA Appliance |
| Classification | Mouthguard, Migraine/tension Headache |
| Applicant | LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD Kingston, CA K7l 4v3 |
| Contact | Ken Luco |
| Correspondent | Ken Luco LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD Kingston, CA K7l 4v3 |
| Product Code | OCO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220012 | K160477 | 000 |
| 00810002220159 | K160477 | 000 |