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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 K130012
Device Name WET PLATINUM PERSONAL LUBRICANT
Applicant
TRIGG LABORATORIES, INC.
28650 Braxton Ave
Valencia,  CA  91355
Applicant Contact ERNIE JOHNSON
Correspondent
TRIGG LABORATORIES, INC.
28650 Braxton Ave
Valencia,  CA  91355
Correspondent Contact ERNIE JOHNSON
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/02/2013
Decision Date 08/22/2013
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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