The following data is part of a premarket notification filed by Healthy Sleep Dental Laboratory with the FDA for Healthy Sleep Appliance.
| Device ID | K123410 |
| 510k Number | K123410 |
| Device Name: | HEALTHY SLEEP APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | HEALTHY SLEEP DENTAL LABORATORY 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden HEALTHY SLEEP DENTAL LABORATORY 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-04-05 |
| Summary: | summary |