FDA 510(k) Application Details - K990800

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

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510(K) Number K990800
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant INTERVASCULAR, INC.
16331 BAY VISTA DR.
CLEARWATER, FL 33760-3130 US
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Contact JAMES S MILLER
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 03/10/1999
Decision Date 01/08/2001
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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