Device Classification Name |
Sleep Appliances With Patient Monitoring
|
510(k) Number |
K150369 |
FOIA Releasable 510(k) |
K150369
|
Device Name |
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder |
Applicant |
SOMNOMED INC. |
7460 Warren Pkwy Ste 190 |
Frisco,
TX
75034
|
|
Applicant Contact |
KIEN T. NGUYEN |
Correspondent |
SOMNOMED, INC. |
7460 WARREN PARKWAY, SUITE 190 |
FRISCO,
TX
75035
|
|
Correspondent Contact |
KIEN T. NGUYEN |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 02/13/2015 |
Decision Date | 06/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|