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FDA 510(k) Application Details - K961246
Device Classification Name
Ring, Annuloplasty
More FDA Info for this Device
510(K) Number
K961246
Device Name
Ring, Annuloplasty
Applicant
ST. JUDE MEDICAL, INC.
ONE LILLEHEI PLAZA
ST. PAUL, MN 55117 US
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Contact
JONAS RUNQUIST
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
04/01/1996
Decision Date
02/14/1997
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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