ENCORE SYSTEM
Prelude Tongue Suspension System
SIESTA MEDICAL, INC.
The following data is part of a premarket notification filed by Siesta Medical, Inc. with the FDA for Encore System.
Pre-market Notification Details
| Device ID | K133680 |
| 510k Number | K133680 |
| Device Name: | ENCORE SYSTEM |
| Classification | Prelude Tongue Suspension System |
| Applicant | SIESTA MEDICAL, INC. 101 CHURCH STREET SUITE 3 Los Gatos, CA 95030 |
| Contact | Michael Kolber |
| Correspondent | Michael Kolber SIESTA MEDICAL, INC. 101 CHURCH STREET SUITE 3 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 | 2013-12-02 |
| Decision Date | 2014-03-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862211000206 | K133680 | 000 |
Trademark Results [ENCORE SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENCORE SYSTEM 73277589 1181947 Dead/Cancelled |
Wenger Corporation 1980-09-12 |
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