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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 K042957
Device Name DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
Applicant
SSL AMERICAS
3583 ENGINEERING DR. SUITE 200
NORCROSS,  GA  30092
Applicant Contact CHRIS ROBINSON
Correspondent
SSL AMERICAS
3583 ENGINEERING DR. SUITE 200
NORCROSS,  GA  30092
Correspondent Contact CHRIS ROBINSON
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/27/2004
Decision Date 02/17/2005
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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