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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 K023405
Device Name TROJAN MINT TINGLE BRAND LATEX CONDOMS
Applicant
ARMKEL, LLC.
469 NORTH HARRISON ST.
princeton,  NJ  08540 -3510
Applicant Contact stephen c kolakowsky
Correspondent
ARMKEL, LLC.
469 NORTH HARRISON ST.
princeton,  NJ  08540 -3510
Correspondent Contact stephen c kolakowsky
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/10/2002
Decision Date 12/16/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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