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FDA 510(k) Applications Submitted by UVision360 Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190827
04/01/2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
UVision360 Inc.
K181909
07/17/2018
Luminelle DTx Hysteroscopy System
UVision360 Inc.
K192278
08/22/2019
Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
UVision360 Inc.
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