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FDA 510(k) Application Details - K070488
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K070488
Device Name
Ring, Annuloplasty
Applicant
MICARDIA CORPORATION
30 HUGHES SUITE 206
IRVINE, CA 92618 US
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Contact
JEFFREY P DUMONTELLE
Other 510(k) Applications for this Contact
Regulation Number
870.3800
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Classification Product Code
KRH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/20/2007
Decision Date
09/04/2008
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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