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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K071626
Device Name DUREX PLAY SOFT & SENSUAL 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
NUC  
Date Received06/14/2007
Decision Date 04/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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