The following data is part of a premarket notification filed by Gergens Orthodontic Lab with the FDA for Dorsal Appliance.
| Device ID | K143591 |
| 510k Number | K143591 |
| Device Name: | Dorsal Appliance |
| Classification | Device, Anti-snoring |
| Applicant | GERGENS ORTHODONTIC LAB 1745 West Deer Valley Rd, Suite 112 Phoenix, AZ 85027 |
| Contact | Chris Morrison |
| Correspondent | Karen E Warden,phd BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 -2141 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-04-15 |
| Summary: | summary |