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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 K091298
Device Name LUBREASE FEMALE LUBRICANT
Applicant
CURVES LIMITED
2 HIGH ROAD
EASTCOTE
PINNER, MIDDLESEX,  GB HA5 2EW
Applicant Contact NILUFER SMITH
Correspondent
CURVES LIMITED
2 HIGH ROAD
EASTCOTE
PINNER, MIDDLESEX,  GB HA5 2EW
Correspondent Contact NILUFER SMITH
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/04/2009
Decision Date 02/24/2010
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
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