Trojan Chain Reaction Personal Lubricant

Lubricant, Personal

CHURCH & DWIGHT CO., INC.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Chain Reaction Personal Lubricant.

Pre-market Notification Details

Device IDK161544
510k NumberK161544
Device Name:Trojan Chain Reaction Personal Lubricant
ClassificationLubricant, Personal
Applicant CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BOULEVARD Ewing,  NJ  08628
ContactLisa Burns
CorrespondentLisa Burns
CHURCH & DWIGHT CO., INC. 500 CHARLES EWING BOULEVARD Ewing,  NJ  08628
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-03
Decision Date2016-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00022600998471 K161544 000
00022600998464 K161544 000

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