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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 K942697
Device Name TROJAN POLYURETHANE CONDOM
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 Received06/08/1994
Decision Date 06/22/1995
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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