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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom with nonoxynol-9
510(k) Number K904273
Device Name MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
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 Number884.5310
Classification Product Code
LTZ  
Date Received09/17/1990
Decision Date 10/31/1990
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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