Device Classification Name |
Tongue Suspension System
|
510(k) Number |
K201238 |
Device Name |
Encore System |
Applicant |
Siesta Medical, Inc. |
101 Church Street, Suite 3 |
Los Gatos,
CA
95030
|
|
Applicant Contact |
Michael Kolber |
Correspondent |
Siesta Medical, Inc. |
101 Church Street, Suite 3 |
Los Gatos,
CA
95030
|
|
Correspondent Contact |
Michael Kolber |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 05/07/2020 |
Decision Date | 10/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|