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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 K901192
Device Name TROJAN-ENZ LUBRI. CONDOMS (MODIFIED LABELING)
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 Received03/12/1990
Decision Date 04/16/1990
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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