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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 K120706
Device Name NIRVANA A PERSONAL LUBRICANT
Original Applicant
CHURCH & DWIGHT CO., INC.
469 north harrison street
princeton,  NJ  08543
Original Contact emily perez
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/08/2012
Decision Date 10/04/2012
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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