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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
510(k) Number K113101
Device Name EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
Applicant
Boston Scientific Corporation
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact SUSAN EICHLER-HUSTON
Correspondent
Boston Scientific Corporation
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact SUSAN EICHLER-HUSTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received10/19/2011
Decision Date 01/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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