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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K955672
Device Name TROJAN POLYURETHANE CONDOM (MODIFICATION)
Applicant
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Applicant Contact STEPHEN C KOLAKOWSKY
Correspondent
CARTER PRODUCTS
HALF ACRE RD.
CRANBURY,  NJ  08512
Correspondent Contact STEPHEN C KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
MOL  
Date Received11/01/1995
Decision Date 08/29/1996
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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