FDA 510(k) Application Details - K083646

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K083646
Device Name Device, Neurovascular Embolization
Applicant MICRUS ENDOVASCULAR CORPORATION
821 FOX LANE
SAN JOSE, CA 95131 US
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Contact PATRICK LEE
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 12/09/2008
Decision Date 01/02/2009
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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