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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 K883413
Device Name TROJAN EXTRA STRENGTH LUBRICATED
Applicant
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Applicant Contact C KOLAKOWSKY
Correspondent
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Correspondent Contact C KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/15/1988
Decision Date 12/08/1988
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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