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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 K153523
Device Name FUSION Vascular Graft
Applicant
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Applicant Contact Mark Dinger
Correspondent
Maquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Mark Dinger
Regulation Number870.3450
Classification Product Code
DSY  
Date Received12/09/2015
Decision Date 02/16/2016
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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