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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 K032227
Device Name DUREX FLAVORED LATEX CONDOM
Applicant
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Applicant Contact KATHLEEN HARRIS
Correspondent
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Correspondent Contact KATHLEEN HARRIS
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/21/2003
Decision Date 03/29/2004
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
Predetermined Change
Control Plan Authorized		 No
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