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FDA 510(k) Application Details - K122612
Device Classification Name
Graft, Vascular, Synthetic/Biologic Composite
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510(K) Number
K122612
Device Name
Graft, Vascular, Synthetic/Biologic Composite
Applicant
MAQUET CARDIOVASCULAR, LLC
45 BARBOUR POND DRIVE
WAYNE, NJ 07470 US
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Contact
MARYLOU INSINGA
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
08/27/2012
Decision Date
09/10/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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