Device Classification Name |
Device, Anti-Snoring
|
510(k) Number |
K201484 |
Device Name |
Somnos Anti-Snoring Mouth Guard |
Applicant |
Koncept Innovators, LLC. |
1619 Executive Ave |
Myrtle Beach,
SC
29577
|
|
Applicant Contact |
Sylvan Newby |
Correspondent |
New World Regulatory Solutions, Inc. |
11700 W. Charleston Blvd, Suite 170-390 |
Las Vegas,
NV
89135
|
|
Correspondent Contact |
Maureen Garner |
Regulation Number | 872.5570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2020 |
Decision Date | 11/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|