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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 K120249
Device Name TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
Applicant
CHURCH & DWIGHT VIRGINIA CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Applicant Contact JOSEPH CICCONE
Correspondent
CHURCH & DWIGHT VIRGINIA CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Correspondent Contact JOSEPH CICCONE
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/27/2012
Decision Date 05/11/2012
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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