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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 K013784
Device Name URETERAL STENT
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact JANET A MCGRATH
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact JANET A MCGRATH
Regulation Number876.4620
Classification Product Code
FAD  
Date Received11/14/2001
Decision Date 08/08/2002
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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