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FDA 510(k) Application Details - K103347
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K103347
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
INTERVASCULAR, SAS
ZONE INDUSTRIELLE ATHELIA I
LACIOTAT 13705 FR
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Contact
PHILIPPE BENSIMON
Other 510(k) Applications for this Contact
Regulation Number
870.3450
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Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2010
Decision Date
02/02/2011
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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