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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 K052302
Device Name HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
Applicant
BOSTON SCIENTIFIC CORP.
2 SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Applicant Contact JENNIFER BOLTON
Correspondent
BOSTON SCIENTIFIC CORP.
2 SCIMED PLACE
MAPLE GROVE,  MN  55311 -1566
Correspondent Contact JENNIFER BOLTON
Regulation Number870.3450
Classification Product Code
MAL  
Date Received08/24/2005
Decision Date 09/12/2005
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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