FDA 510(k) Application Details - K032810

Device Classification Name Ring, Annuloplasty

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510(K) Number K032810
Device Name Ring, Annuloplasty
Applicant MEDTRONIC HEART VALVES
8299 CENTRAL AVE., N.E.
M.S. P108
MINNEAPOLIS, MN 55432-3576 US
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Contact JULIE SHERMAN
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Regulation Number 870.3800

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Classification Product Code KRH
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Date Received 09/09/2003
Decision Date 12/05/2003
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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