FDA 510(k) Application Details - K062172

Device Classification Name

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510(K) Number K062172
Device Name FETCH ASPIRATION CATHETER
Applicant POSSIS MEDICAL, INC.
9055 EVERGREEN BLVD., N.W.
COON RAPIDS, MN 55433-8003 US
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Contact FRANK B FREEDMAN
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Regulation Number

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Classification Product Code QEZ
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Date Received 07/31/2006
Decision Date 09/20/2006
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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