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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 N. Harrison St.
Princeton,  NJ  08543
Applicant Contact EMILY PEREZ
Correspondent
Church & Dwight Co., Inc.
469 N. Harrison St.
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
Predetermined Change
Control Plan Authorized		 No
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