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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Metallic, Expandable, Duodenal
510(k) Number K062750
Device Name WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
Applicant
Boston Scientific Corp
One Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact ALLYSON BARFORD
Correspondent
Boston Scientific Corp
One Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact ALLYSON BARFORD
Regulation Number878.3610
Classification Product Code
MUM  
Date Received09/14/2006
Decision Date 12/04/2006
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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