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FDA 510(k) Application Details - K061772
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
More FDA Info for this Device
510(K) Number
K061772
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA AVE.
EXTON, PA 19341 US
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Contact
ROBIN M FATZINGER
Other 510(k) Applications for this Contact
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
06/23/2006
Decision Date
07/11/2006
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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