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 |