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FDA 510(k) Application Details - K093231
Device Classification Name
Graft, Vascular, Synthetic/Biologic Composite
More FDA Info for this Device
510(K) Number
K093231
Device Name
Graft, Vascular, Synthetic/Biologic Composite
Applicant
LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON, MA 01803 US
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Contact
ERIN DALY
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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
10/14/2009
Decision Date
01/14/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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