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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K181909
Device Name Luminelle DTx Hysteroscopy System
Applicant
Uvision360, Inc.
4441-106 Six Forks Rd., #179
Raleigh,  NC  27609
Applicant Contact Allison London Brown
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
HIH  
Date Received07/17/2018
Decision Date 08/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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