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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lubricant, personal
510(k) Number K201612
Device Name Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
Viramal Limited
106 New Bond Street
London,  GB W1S 1DN
Applicant Contact Simona Fiore
Biologics Consulting Group, Inc
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Joshua Crist
Regulation Number884.5300
Classification Product Code
Date Received06/15/2020
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