FDA 510(k) Application Details - K061332

Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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510(K) Number K061332
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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Date Received 05/12/2006
Decision Date 08/11/2006
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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