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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K013433
Device Name TROJAN PASSION BERRY GEL
Applicant
ARMKEL LLC
P.O. BOX 1001 HALF ACRE RD.
CRANBURY,,  NJ  08512
Applicant Contact STEPHEN C KOLAKOWSKY
Correspondent
ARMKEL LLC
P.O. BOX 1001 HALF ACRE RD.
CRANBURY,,  NJ  08512
Correspondent Contact STEPHEN C KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/16/2001
Decision Date 03/05/2002
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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