FDA 510(k) Application Details - K071634

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K071634
Device Name Device, Neurovascular Embolization
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact SHILPA PREM
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 06/15/2007
Decision Date 07/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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