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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 K180764
Device Name TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)
Applicant
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Applicant Contact Joelle Reinson
Correspondent
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Correspondent Contact Joelle Reinson
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/23/2018
Decision Date 08/01/2018
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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