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FDA 510(k) Application Details - K073563
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
More FDA Info for this Device
510(K) Number
K073563
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
ST. JUDE MEDICAL
6550 WEDGWOOD RD. NORTH
SUITE 150
MAPLE GROVE, MN 55311 US
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Contact
LINH PHAM
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Regulation Number
870.1250
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Classification Product Code
NFA
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More FDA Info for this Product Code
Date Received
12/19/2007
Decision Date
01/31/2008
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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