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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 K060323
Device Name ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact JENNIFER KIMBALL
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact JENNIFER KIMBALL
Regulation Number878.3610
Classification Product Code
MQR  
Date Received02/09/2006
Decision Date 05/12/2006
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
Recalls CDRH Recalls
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