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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 K190827
Device Name Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
Applicant
Uvision360, Inc.
158 Wind Chime Ct. ,Suite #201
Raleigh,  NC  27615
Applicant Contact Allison London Brown
Correspondent
MethodSense, Inc.
1 Copley Pkwy.,
Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
FAJ  
Date Received04/01/2019
Decision Date 06/06/2019
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
Predetermined Change
Control Plan Authorized		 No
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