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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K002133
Device Name NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact JODI LYNN GREENNIZEN
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact JODI LYNN GREENNIZEN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/14/2000
Decision Date 10/12/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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