Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K090503 |
Device Name |
ZQUIET MOUTHPIECE |
Applicant |
SLEEPING WELL, LLC |
1468 HARWELL AVE. |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Regulation Number | 872.5570
|
Classification Product Code |
|
Date Received | 02/25/2009 |
Decision Date | 03/10/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|