Elegant 2 In 1 Vaginal Moisturizer, Elegant Advanced 5

Lubricant, Personal

Viramal Limited

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.

Pre-market Notification Details

Device IDK201612
510k NumberK201612
Device Name:Elegant 2 In 1 Vaginal Moisturizer, Elegant Advanced 5
ClassificationLubricant, Personal
Applicant Viramal Limited 106 New Bond Street London,  GB W1s 1dn
ContactSimona Fiore
CorrespondentJoshua Crist
Biologics Consulting Group, Inc 1555 King Street, Suite 300 Alexandria,  VA  22314
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-15
Decision Date2021-09-02

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