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FDA 510(k) Application Details - K052280
Device Classification Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
More FDA Info for this Device
510(K) Number
K052280
Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant
BOSTON SCIENTIFIC CORP.
2011 STIERLIN CT.
MOUNTAIN VIEW, CA 94043-4655 US
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Contact
DEBBIE MCINTIRE
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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
08/22/2005
Decision Date
11/07/2005
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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