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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 K954290
Device Name WALLSTENT ENTERAL ENDOPROTHESIS
Applicant
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Applicant Contact Kathy Jo Fahey
Correspondent
Boston Scientific Scimed, Inc.
5905 Nathan Ln.
Plymouth,  MN  55442
Correspondent Contact Kathy Jo Fahey
Regulation Number878.3610
Classification Product Code
MQR  
Date Received09/14/1995
Decision Date 07/10/1996
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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