FDA 510(k) Application Details - K081989

Device Classification Name

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510(K) Number K081989
Device Name MODIFICATION TO FETCH ASPIRATION CATHETER
Applicant POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
MINNEAPOLIS, MN 55433-8003 US
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Contact MIKE BURNSIDE
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Regulation Number

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Classification Product Code QEZ
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Date Received 07/14/2008
Decision Date 09/26/2008
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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