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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 K001212
Device Name TROJAN EXTRA LARGE LATEX CONDOM
Applicant
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
cranbury,  NJ  08512
Applicant Contact stephen c kolakowsky
Correspondent
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
cranbury,  NJ  08512
Correspondent Contact stephen c kolakowsky
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received04/14/2000
Decision Date 05/09/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
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