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FDA 510(k) Application Details - K071327
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K071327
Device Name
Ring, Annuloplasty
Applicant
SORIN BIOMEDICA CARDIO S.R.L.
1300 EAST ANDERSON LANE
AUSTIN, TX 78752-1793 US
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Contact
HEATHER CRAWFORD
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
05/11/2007
Decision Date
08/10/2007
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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