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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 K202921
Device Name Uro-G Cystoscope
Applicant
Uroviu Corporation
5337 - 14th Place SE
Bellevue,  WA  98006
Applicant Contact Thomas Lawson
Correspondent
Uroviu Corporation
5337 - 14th Place SE
Bellevue,  WA  98006
Correspondent Contact Thomas Lawson
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received09/29/2020
Decision Date 05/04/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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