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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K153049
Device Name LithoVue System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01756
Applicant Contact JEANNE O'TOOLE
Correspondent
Third Party Review Group, LLC
45 Rockefeller Plz., Suite 2000
New York,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
FGB  
Date Received10/20/2015
Decision Date 11/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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