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FDA 510(k) Application Details - K023691
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
More FDA Info for this Device
510(K) Number
K023691
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
BOSTON SCIENTIFIC EPI
2525 WALSH AVE.
SANTA CLARA, CA 95051-1316 US
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Contact
TIMOTHY J JOHNSON
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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
11/01/2002
Decision Date
06/04/2003
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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