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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 K160211
Device Name Wet Original Personal Lubricant
Applicant
Trigg Laboratories D/B/A Wet International
28650 Braxton Ave.
Valencia,  CA  91355
Applicant Contact ERICA LORING
Correspondent
Trigg Laboratories D/B/A Wet International
28650 Braxton Ave.
Valencia,  CA  91355
Correspondent Contact ERICA LORING
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/28/2016
Decision Date 04/27/2016
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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