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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 K210814
Device Name Coconu Water Based Personal Lubricant
Coconu, LLC.
1968 E. Ashley Mesa Lane
Sandy,  UT  84092
Applicant Contact Taylor Warnick
Med-Device Consulting, Inc.
5804 Rainbow Hill Road
Agoura Hills,  CA  91301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
Date Received03/17/2021
Decision Date 06/14/2021
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