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510(k) K201612

Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 by Viramal Limited — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2021
Date Received
June 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Other clearances by Viramal Limited

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