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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 K180104
Device Name Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
Applicant
Church & Dwight Co., Inc
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Applicant Contact Joelle Reinson
Correspondent
Church & Dwight Co., Inc
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Correspondent Contact Joelle Reinson
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/16/2018
Decision Date 03/14/2018
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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