The following data is part of a premarket notification filed by Viramal Limited with the FDA for Elegant 2 In 1 Vaginal Moisturizer, Elegant Advanced 5.
| Device ID | K201612 |
| 510k Number | K201612 |
| Device Name: | Elegant 2 In 1 Vaginal Moisturizer, Elegant Advanced 5 |
| Classification | Lubricant, Personal |
| Applicant | Viramal Limited 106 New Bond Street London, GB W1s 1dn |
| Contact | Simona Fiore |
| Correspondent | Joshua Crist Biologics Consulting Group, Inc 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2021-09-02 |