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FDA 510(k) Application Details - K052302
Device Classification Name
Graft, Vascular, Synthetic/Biologic Composite
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510(K) Number
K052302
Device Name
Graft, Vascular, Synthetic/Biologic Composite
Applicant
BOSTON SCIENTIFIC CORP.
2 SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact
JENNIFER BOLTON
Other 510(k) Applications for this Contact
Regulation Number
870.3450
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Classification Product Code
MAL
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More FDA Info for this Product Code
Date Received
08/24/2005
Decision Date
09/12/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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