FDA 510(k) Application Details - K103347

Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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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
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Regulation Number 870.3450

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Classification Product Code DSY
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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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