Device Classification Name |
device, anti-snoring
|
510(k) Number |
K093407 |
Device Name |
ZQUIET MOUTHPIECE |
Applicant |
SLEEPING WELL, LLC |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
SLEEPING WELL, LLC |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 11/02/2009 |
Decision Date | 06/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|