The following data is part of a premarket notification filed by Selane Products, Inc. with the FDA for Sml-osa2 Appliances.
| Device ID | K162816 |
| 510k Number | K162816 |
| Device Name: | SML-OSA2 Appliances |
| Classification | Device, Jaw Repositioning |
| Applicant | SELANE PRODUCTS, INC. 9129 LURLINE AVENUE Chatsworth, CA 91311 |
| Contact | John Christian |
| Correspondent | Carolyn M. Primus PRIMUS CONSULTING 7046 OWL'S NEST TERRACE Bradenton, FL 34203 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-06 |
| Decision Date | 2017-07-27 |
| Summary: | summary |