The following data is part of a premarket notification filed by Siesta Medical, Inc. with the FDA for Encore System.
| Device ID | K213159 |
| 510k Number | K213159 |
| Device Name: | Encore System |
| Classification | Prelude Tongue Suspension System |
| Applicant | Siesta Medical, Inc. 101 Church Street Los Gatos, CA 95030 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber Siesta Medical, Inc. 101 Church Street Los Gatos, CA 95030 |
| Product Code | ORY |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2021-12-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENCORE SYSTEM 73277589 1181947 Dead/Cancelled |
Wenger Corporation 1980-09-12 |