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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 K050828
Device Name TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
Applicant
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Applicant Contact STEPHEN C KOLAKOWSKY
Correspondent
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Correspondent Contact STEPHEN C KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
MOL  
Date Received04/01/2005
Decision Date 02/28/2006
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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