FDA 510(k) Application Details - K060124

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

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510(K) Number K060124
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact KAREN HALL
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 01/18/2006
Decision Date 03/30/2006
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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