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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 K150886
Device Name Trojan Riviera Personal Lubricant
Applicant
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Applicant Contact LISA BURNS
Correspondent
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Correspondent Contact LISA BURNS
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/02/2015
Decision Date 07/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02297841
NCT02309294
NCT02320214
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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