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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 K030769
Device Name ULTRAFLEX PRECISION COLONIC STENT
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Applicant Contact KATHLEEN MORAHAN
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,,  MA  01760 -1537
Correspondent Contact KATHLEEN MORAHAN
Regulation Number878.3610
Classification Product Code
MQR  
Date Received03/11/2003
Decision Date 07/14/2003
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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