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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 K001338
FOIA Releasable 510(k) K001338
Device Name MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact ABBY LIPMAN
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact ABBY LIPMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/27/2000
Decision Date 08/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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