FDA 510(k) Application Details - K022242

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

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510(K) Number K022242
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant INTERVASCULAR
20 WALNUT ST.
SUITE 12
WELLESLEY, MA 02481 US
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Contact Amy Aulwes
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 07/11/2002
Decision Date 08/14/2002
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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