FDA 510(k) Application Details - K011395

Device Classification Name Ring, Annuloplasty

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510(K) Number K011395
Device Name Ring, Annuloplasty
Applicant MEDTRONIC VASCULAR
8299 CENTRAL AVE., N.E.
MAIL STOP: P108
MINNEAPOLIS, MN 55432 US
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Contact CHARLES DOWD
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Regulation Number 870.3800

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Classification Product Code KRH
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Date Received 05/07/2001
Decision Date 07/12/2001
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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