BioGenesis Fertility Lubricant

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Good Clean Love, Inc.

The following data is part of a premarket notification filed by Good Clean Love, Inc. with the FDA for Biogenesis Fertility Lubricant.

Pre-market Notification Details

Device IDK190872
501k NumberK190872
Device Name:BioGenesis Fertility Lubricant
ClassificationLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Applicant Good Clean Love, Inc. 207 W. 5th Avenue Eugene,  OR  97401
ContactWendy Strgar
CorrespondentAbhishek Gurnani
Amin Talati Upadhye, LLP 100 South Wacker Drive, Suite 2000 Chicago,  IL  60606
Product CodePEB  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyObstetrics/Gynecology
501k Review PanelObstetrics/Gynecology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-03
Decision Date2019-11-07

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