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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Graft, Vascular, Synthetic/Biologic Composite
510(k) Number K021213
Device Name MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact JENNIFER BOLTON
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact JENNIFER BOLTON
Regulation Number870.3450
Classification Product Code
MAL  
Date Received04/17/2002
Decision Date 04/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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