Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K132506 |
Device Name |
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY |
Applicant |
MICHAEL D. WILLIAMS,DDS PA |
10991 SW 42ND PL |
DAVIE,
FL
33328
|
|
Applicant Contact |
MICHAEL D WILLIAMS |
Correspondent |
MICHAEL D. WILLIAMS,DDS PA |
10991 SW 42ND PL |
DAVIE,
FL
33328
|
|
Correspondent Contact |
MICHAEL D WILLIAMS |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 08/12/2013 |
Decision Date | 05/29/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|