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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 K032930
Device Name ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Applicant Contact KATHLEEN MORAHAN
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Correspondent Contact KATHLEEN MORAHAN
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/22/2003
Decision Date 10/23/2003
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
Recalls CDRH Recalls
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