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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Condom, Synthetic
510(k) Number K240379
Device Name TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
Applicant
Church & Dwight Co., Inc.
469 N. Harrison Streeet
Princeton,  NJ  08543
Applicant Contact Lori Barr
Correspondent
Full Circle Regulatory Consulting, LLC
107 Casablanca Court
Cary,  NC  27519
Correspondent Contact Dawn Reilly-O'Dell
Regulation Number884.5300
Classification Product Code
MOL  
Date Received02/07/2024
Decision Date 10/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT05370196
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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