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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 K100767
Device Name TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
Applicant
Church & Dwight Co., Inc.
469 N. Harrison St.
Princeton,  NJ  08543
Applicant Contact JOSEPH CICCONE
Correspondent
Church & Dwight Co., Inc.
469 N. Harrison St.
Princeton,  NJ  08543
Correspondent Contact JOSEPH CICCONE
Regulation Number884.5300
Classification Product Code
MOL  
Date Received03/18/2010
Decision Date 04/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01311726
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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