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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 K040185
Device Name DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
Applicant
SSL AMERICAS
3585 ENGINEERING DR.
NORCROSS,  GA  30092
Applicant Contact KATHLEEN J HARRIS
Correspondent
SSL AMERICAS
3585 ENGINEERING DR.
NORCROSS,  GA  30092
Correspondent Contact KATHLEEN J HARRIS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/27/2004
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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