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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 K191480
Device Name Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)
Applicant
Trigg Laboratories, Inc. D/B/A Wet International
4220 W Windmill Ln., Suite 140
Las Vegas,  CA  89139
Applicant Contact Louie Goryoka
Correspondent
Trigg Laboratories, Inc. D/B/A Wet International
4220 W Windmill Ln., Suite 140
Las Vegas,  CA  89139
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/04/2019
Decision Date 10/11/2019
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
Predetermined Change
Control Plan Authorized		 No
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