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FDA 510(k) Application Details - K042734
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K042734
Device Name
Ring, Annuloplasty
Applicant
ST. JUDE MEDICAL, INC.
ONE LILLEHEI PLAZA
ST. PAUL, MN 55117 US
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Contact
WILLIAM MCKELVEY
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
10/01/2004
Decision Date
12/17/2004
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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