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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom
510(k) Number K221431
Device Name TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
Applicant
Church & Dwight Co., Inc.
500 Charles Ewing Blvd.
Ewing,  NJ  08628
Applicant Contact Supreet Sahota-Bhatti
Correspondent
Full Circle Regulatory Consulting, LLC
107 Casablanca Ct.
Cary,  NC  27519
Correspondent Contact Dawn Reilly-O'Dell
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/17/2022
Decision Date 07/14/2022
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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