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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 K161915
Device Name Trojan XOXO Ribbed 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 Received07/12/2016
Decision Date 09/09/2016
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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