The following data is part of a premarket notification filed by Luco Hybrid Osa Appliance Inc. with the FDA for Luco Hybrid Osa Appliance.
| Device ID | K130797 |
| 510k Number | K130797 |
| Device Name: | LUCO HYBRID OSA APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD Kingston, Ontario, CA K7l 5h6 |
| Contact | Ken Luco |
| Correspondent | Ken Luco LUCO HYBRID OSA APPLIANCE INC. 1419 BUTTERNUT CREEK ROAD Kingston, Ontario, CA K7l 5h6 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220241 | K130797 | 000 |