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FDA 510(k) Application Details - K032250
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K032250
Device Name
Ring, Annuloplasty
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE, CA 92614 US
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Contact
SUSAN REYNOLDS
Other 510(k) Applications for this Contact
Regulation Number
870.3800
More FDA Info for this Regulation Number
Classification Product Code
KRH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2003
Decision Date
08/26/2003
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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