JO H2O Jelly Original Personal Lubricant

Lubricant, Personal

United Consortium

The following data is part of a premarket notification filed by United Consortium with the FDA for Jo H2o Jelly Original Personal Lubricant.

Pre-market Notification Details

Device IDK183584
510k NumberK183584
Device Name:JO H2O Jelly Original Personal Lubricant
ClassificationLubricant, Personal
Applicant United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
ContactStephanie Morris
CorrespondentStephanie Morris
United Consortium 29000 N. Hancock Pkwy. Valencia,  CA  91355
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-04-17

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