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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom, synthetic
510(k) Number K171639
Device Name Trojan Supra Lubricated Polyurethane Male Condom
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
MOL  
Date Received06/02/2017
Decision Date 08/01/2017
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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