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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 K122477
Device Name LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT
Original Applicant
ANSELL HEALTHCARE PRODUCTS LLC
4 los verdes drive
san luis obispo,  CA  93401
Original Contact donna digangi
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/14/2012
Decision Date 02/19/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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