Pre-Seed™ Fertility Lubricant

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Church & Dwight Co., Inc.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Pre-seed™ Fertility Lubricant.

Pre-market Notification Details

Device IDK193450
510k NumberK193450
Device Name:Pre-Seed™ Fertility Lubricant
ClassificationLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Applicant Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing,  NJ  08628
ContactJoelle Reinson
CorrespondentJoelle Reinson
Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing,  NJ  08628
Product CodePEB  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-13
Decision Date2020-07-23

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