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FDA 510(k) Application Details - K052970
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K052970
Device Name
Ring, Annuloplasty
Applicant
MEDTRONIC HEART VALVES
8299 CENTRAL AVE., N.E.
SPRING LAKE PARK, MN 55432-3576 US
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Contact
PHIL NEURURER
Other 510(k) Applications for this Contact
Regulation Number
870.3800
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Classification Product Code
KRH
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More FDA Info for this Product Code
Date Received
10/24/2005
Decision Date
01/11/2006
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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