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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 K042958
Device Name DUREX PLAY TINGLING LUBRICANT
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
NUC  
Date Received10/27/2004
Decision Date 04/08/2005
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 Yes
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