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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 K183050
Device Name GLISSANT Intimate Lubricant
Applicant
Vjuvenate, LLC
3435 Ocean Park Blvd, Suite 107
Santa Monica,  CA  90405
Applicant Contact Karyn Eilber
Correspondent
Vjuvenate, LLC
3435 Ocean Park Blvd, Suite 107
Santa Monica,  CA  90405
Correspondent Contact Karyn Eilber
Regulation Number884.5300
Classification Product Code
NUC  
Date Received11/02/2018
Decision Date 07/08/2019
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
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