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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 K161544
Device Name Trojan Chain Reaction Personal Lubricant
Applicant
CHURCH & DWIGHT CO., INC.
500 CHARLES EWING BOULEVARD
EWING,  NJ  08628
Applicant Contact Lisa Burns
Correspondent
CHURCH & DWIGHT CO., INC.
500 CHARLES EWING BOULEVARD
EWING,  NJ  08628
Correspondent Contact Lisa Burns
Regulation Number884.5300
Classification Product Code
NUC  
Date Received06/03/2016
Decision Date 08/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT02737618
NCT02737631
NCT02737852
Reviewed by Third Party No
Combination Product No
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