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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K072169
Device Name DUREX SYNTHETIC POLYISOPRENE MALE CONDOM
Applicant
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Applicant Contact CHRIS ROBINSON
Correspondent
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Correspondent Contact CHRIS ROBINSON
Regulation Number884.5300
Classification Product Code
MOL  
Date Received08/06/2007
Decision Date 06/19/2008
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
Recalls CDRH Recalls
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