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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K161545
Device Name Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe 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
HIS  
Date Received06/03/2016
Decision Date 08/26/2016
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
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