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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
Models M00558600,M00558610,M00558620,M22558630,M00558640,M00558650,M00558660, M00558670,M00558680,M00558690,M00558700,M00558710
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 (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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