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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, biliary, diagnostic
510(k) Number K112994
Device Name CRE DITATATION BALLON
Original Applicant
Boston Scientific Corporation
100 boston scientific way
marlborough,  MA  01752
Original Contact janis taranto
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/07/2011
Decision Date 02/10/2012
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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