JO Actively Trying Personal Lubricant

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

United Consortium

The following data is part of a premarket notification filed by United Consortium with the FDA for Jo Actively Trying Personal Lubricant.

Pre-market Notification Details

Device IDK182585
510k NumberK182585
Device Name:JO Actively Trying Personal Lubricant
ClassificationLubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Applicant United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
ContactStephanie Morris
CorrespondentStephanie Morris
United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
Product CodePEB  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-20
Decision Date2019-04-26

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