Cystoscope And Accessories, Flexible/rigid

Uvision360, Inc.

The following data is part of a premarket notification filed by Uvision360, Inc. with the FDA for Luminelle Dtx System.

Pre-market Notification Details

Device IDK210512
510k NumberK210512
Device Name:LUMINELLE DTx System
ClassificationCystoscope And Accessories, Flexible/rigid
Applicant Uvision360, Inc. 158 Wind Chime Ct. ,Suite #201 Raleigh,  NC  27615
ContactAllison London Brown
CorrespondentRita King
MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville,  NC  27560
Product CodeFAJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-23
Decision Date2021-06-30

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