The following data is part of a premarket notification filed by Gergens Orthodontic Lab with the FDA for Acrylic Herbst Appliance.
| Device ID | K113126 |
| 510k Number | K113126 |
| Device Name: | ACRYLIC HERBST APPLIANCE |
| Classification | Device, Anti-snoring |
| Applicant | GERGENS ORTHODONTIC LAB 11825 State Route 40 Ste 101 Dunlap, IL 61525 |
| Contact | Karen E Warden, Phd |
| Correspondent | Karen E Warden, Phd GERGENS ORTHODONTIC LAB 11825 State Route 40 Ste 101 Dunlap, IL 61525 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2013-07-17 |
| Summary: | summary |