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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Colonic, Metallic, Expandable
510(k) Number K200257
Device Name WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Catherine Sanford
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Catherine Sanford
Regulation Number878.3610
Classification Product Code
MQR  
Subsequent Product Code
MUM  
Date Received02/03/2020
Decision Date 04/17/2020
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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