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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 K122054
Device Name LIFESTYLES NATURAL PERSONAL LUBRICANT
Applicant
ANSELL HEALTHCARE PRODUCTS, LLC
4 los verdes drive
san luis obispo,  CA  93401
Contact donna digangi
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/13/2012
Decision Date 02/14/2013
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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