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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic ultrasound system, gastroenterology-urology
510(k) Number K112198
Model M00550040, M00550041
Device Name EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
Original Applicant
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough,  MA  01752
Original Contact ashley pyle
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received08/01/2011
Decision Date 09/14/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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