VR101 Lubricating Intravaginal Ring

Lubricant, Personal

J3 Bioscience, Inc.

The following data is part of a premarket notification filed by J3 Bioscience, Inc. with the FDA for Vr101 Lubricating Intravaginal Ring.

Pre-market Notification Details

Device IDK203377
510k NumberK203377
Device Name:VR101 Lubricating Intravaginal Ring
ClassificationLubricant, Personal
Applicant J3 Bioscience, Inc. 825 North 300 West, Suite N231 Salt Lake City,  UT  84103
ContactR. Tyler Mccabe
CorrespondentR. Tyler Mccabe
J3 Bioscience, Inc. 825 North 300 West, Suite N231 Salt Lake City,  UT  84103
Product CodeNUC  
CFR Regulation Number884.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-17
Decision Date2021-05-20

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