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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hysteroscope (and accessories)
510(k) Number K192278
Device Name Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
UVision360 Inc.
158 Wind Chime Ct. Ste. 201
Raleigh,  NC  27615
Applicant Contact Allison London Brown
MethodSense, Inc.
1 Copley Pkwy, Ste. 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number884.1690
Classification Product Code
Subsequent Product Code
Date Received08/22/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No