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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 K080332
Device Name POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact ASHLEY PYLE
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact ASHLEY PYLE
Regulation Number878.3610
Classification Product Code
ESW  
Date Received02/07/2008
Decision Date 09/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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