Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K150615 |
Device Name |
Vaginal Moisturizing Gel |
Applicant |
COMBE INCORPORATED |
1101 WESTCHESTER AVE. |
WHITE PLAINS,
NY
10604
|
|
Applicant Contact |
Pushpa Rao |
Correspondent |
COMBE INCORPORATED |
1101 WESTCHESTER AVE. |
WHITE PLAINS,
NY
10604
|
|
Correspondent Contact |
Pushpa Rao |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 03/10/2015 |
Decision Date | 05/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|