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FDA 510(k) Application Details - K984182
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K984182
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
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Contact
TIMOTHY J KAPPERS
Other 510(k) Applications for this Contact
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
11/23/1998
Decision Date
02/01/1999
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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