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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 K012952
Device Name HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
Applicant
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Applicant Contact JENNIFER BOLTON
Correspondent
BOSTON SCIENTIFIC/MEDI-TECH
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Correspondent Contact JENNIFER BOLTON
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/04/2001
Decision Date 10/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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