Passion Natural Water Based Lubricant

Lubricant, Personal


The following data is part of a premarket notification filed by Xr Llc with the FDA for Passion Natural Water Based Lubricant.

Pre-market Notification Details

Device IDK202017
510k NumberK202017
Device Name:Passion Natural Water Based Lubricant
ClassificationLubricant, Personal
Applicant XR LLC 5251 Pipeline Lane Huntington Beach,  CA  92649
ContactLouie Goryoka
CorrespondentLouie Goryoka
Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills,  CA  91301
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2021-01-08

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