FDA 510(k) Application Details - K060078

Device Classification Name Device, Vascular, For Promoting Embolization

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510(K) Number K060078
Device Name Device, Vascular, For Promoting Embolization
Applicant Boston Scientific Corporation
100 BOSTON SCIENTFIC WAY
MARLBOROUGH, MA 01752 US
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Contact CHRISTINE M CAMERON
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Regulation Number 870.3300

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Classification Product Code KRD
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Date Received 01/10/2006
Decision Date 01/31/2006
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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