Device Classification Name |
tongue suspension system
|
510(k) Number |
K133680 |
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 | 12/02/2013 |
Decision Date | 03/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|