Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K121761 |
Device Name |
SOMNOGUARD SP SOFT |
Applicant |
TOMED DR. TOUSSAINT GMBH |
854 US ROUTE 3 |
HOLDERNESS,
NH
03245
|
|
Applicant Contact |
SCOTT WHITCOMB |
Correspondent |
TOMED DR. TOUSSAINT GMBH |
854 US ROUTE 3 |
HOLDERNESS,
NH
03245
|
|
Correspondent Contact |
SCOTT WHITCOMB |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|