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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 K123427
FOIA Releasable 510(k) K123427
Device Name NIRVANA D PERSONAL LUBRICANT (TBD)
Applicant
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Applicant Contact EMILY PEREZ
Correspondent
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Correspondent Contact EMILY PEREZ
Regulation Number884.5300
Classification Product Code
NUC  
Date Received11/07/2012
Decision Date 06/28/2013
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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