FDA 510(k) Application Details - K052964

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

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510(K) Number K052964
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant BOSTON SCIENTIFIC CORP.
TWO SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact KATIE GERBENSKY
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 10/21/2005
Decision Date 01/06/2006
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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