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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K163399
Device Name Tria Firm Ureteral Stent
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Christine Shoemaker
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Christine Shoemaker
Regulation Number876.4620
Classification Product Code
FAD  
Date Received12/05/2016
Decision Date 06/22/2017
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
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