Device Classification Name |
lubricant, personal
|
510(k) Number |
K201612 |
Device Name |
Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 |
Applicant |
Viramal Limited |
106 New Bond Street |
London,
GB
W1S 1DN
|
|
Applicant Contact |
Simona Fiore |
Correspondent |
Biologics Consulting Group, Inc |
1555 King Street, Suite 300 |
Alexandria,
VA
22314
|
|
Correspondent Contact |
Joshua Crist |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 06/15/2020 |
Decision Date | 09/02/2021 |
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
|
|
|