Trojan XOXO Ribbed Male Natural Rubber Latex Condom With Silicone And Aloe 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 Xoxo Ribbed Male Natural Rubber Latex Condom With Silicone And Aloe Lubricant.

Pre-market Notification Details

Device IDK161915
510k NumberK161915
Device Name:Trojan XOXO Ribbed Male Natural Rubber Latex Condom With Silicone And Aloe Lubricant
ClassificationCondom
Applicant CHURCH & DWIGHT CO.,INC. 500 CHARLES EWING BLVD Ewing,  NJ  08628
ContactLisa Burns
CorrespondentLisa Burns
CHURCH & DWIGHT CO.,INC. 500 CHARLES EWING BLVD Ewing,  NJ  08628
Product CodeHIS  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-12
Decision Date2016-09-09
Summary:summary

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