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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 K020659
FOIA Releasable 510(k) K020659
Device Name DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Applicant
SSL AMERICAS, INC.
3585 ENGINEERING DR.; STE 200
P.O. BOX 926090
norcross,  GA  30092 -9214
Applicant Contact joyce ning
Correspondent
SSL AMERICAS, INC.
3585 ENGINEERING DR.; STE 200
P.O. BOX 926090
norcross,  GA  30092 -9214
Correspondent Contact joyce ning
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/01/2002
Decision Date 03/29/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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