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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 K912901
Device Name TROJAN (TM-TBD) CONDOM
Applicant
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Applicant Contact STEPHEN KOLAKOWSKY
Correspondent
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Correspondent Contact STEPHEN KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received07/02/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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