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FDA 510(k) Application Details - K062870
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
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510(K) Number
K062870
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact
ROBIN M FATZINGER
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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
09/25/2006
Decision Date
10/20/2006
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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