The following data is part of a premarket notification filed by Easy Access Orthodontics, Inc. with the FDA for Lariat Palate Expander.
| Device ID | K926427 |
| 510k Number | K926427 |
| Device Name: | LARIAT PALATE EXPANDER |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | EASY ACCESS ORTHODONTICS, INC. 27001 LA PAZ RD., #236 Mission Viejo, CA 92691 |
| Contact | Jeffrey J Staples |
| Correspondent | Jeffrey J Staples EASY ACCESS ORTHODONTICS, INC. 27001 LA PAZ RD., #236 Mission Viejo, CA 92691 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-23 |
| Decision Date | 1994-01-26 |