TROJAN(TM) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant

Condom

Church & Dwight Co., Inc.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan(tm) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant.

Pre-market Notification Details

Device IDK221431
510k NumberK221431
Device Name:TROJAN(TM) Her Pleasure Warming Male Natural Rubber Latex Condom With Warming Lubricant
ClassificationCondom
Applicant Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing,  NJ  08628
ContactSupreet Sahota-Bhatti
CorrespondentDawn Reilly-O'Dell
Full Circle Regulatory Consulting, LLC 107 Casablanca Court Cary,  NC  27519
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-17
Decision Date2022-07-14

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