FDA 510(k) Application Details - K073324

Device Classification Name Ring, Annuloplasty

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510(K) Number K073324
Device Name Ring, Annuloplasty
Applicant MEDTRONIC INC.
8299 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432 US
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Contact BECKY HANNACK
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Regulation Number 870.3800

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Classification Product Code KRH
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Date Received 11/27/2007
Decision Date 03/13/2008
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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