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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
Device Name ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact JANIS F TARANTO
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact JANIS F TARANTO
Regulation Number878.3610
Classification Product Code
ESW  
Date Received04/02/2012
Decision Date 05/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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