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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. Ste. 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
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