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FDA 510(k) Application Details - K011395
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
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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More FDA Info for this Product Code
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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