The following data is part of a premarket notification filed by Siesta Medical, Inc with the FDA for Encore System.
Device ID | K183310 |
510k Number | K183310 |
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 | 2018-11-29 |
Decision Date | 2019-05-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENCORE SYSTEM 73277589 1181947 Dead/Cancelled |
Wenger Corporation 1980-09-12 |