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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 K012883
Device Name ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact KATHLEEN MORAHAN
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact KATHLEEN MORAHAN
Regulation Number878.3610
Classification Product Code
ESW  
Subsequent Product Codes
FGE   JCT  
Date Received08/28/2001
Decision Date 10/12/2001
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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