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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, esophageal
510(K) Number K120983
Models M00513720, M00513800, M00513810, M00513820, M00513730,MM00513740, M00513750, M00514200, M00513830, M00514220, M00514230, M00514210, M00513840, M00513850, M00513860, M00514240, M00514250, M00513700, M00513710
Device Name ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough,  MA  01752
Contact janis f taranto
Regulation Number878.3610
Classification Product Code
ESW  
Date Received04/02/2012
Decision Date 05/02/2012
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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