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FDA 510(k) Application Details - K071778
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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510(K) Number
K071778
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
GRAFTCATH INC.
6545 CITY WEST PARKWAY
EDEN PRAIRIE, MN 55344 US
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Contact
LAURIE LYNCH
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Regulation Number
870.3450
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Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
07/02/2007
Decision Date
01/30/2008
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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