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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
Applicant
Coconu, LLC.
1968 E. Ashley Mesa Lane
Sandy,  UT  84092
Applicant Contact Taylor Warnick
Correspondent
Med-Device Consulting, Inc.
5804 Rainbow Hill Road
Agoura Hills,  CA  91301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
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
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