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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 K023870
Device Name FLEXIMA BILIARY CATHETER
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Applicant Contact NICHOLAS CONDAKES
Correspondent
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Correspondent Contact NICHOLAS CONDAKES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/20/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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