FDA 510(k) Application Details - K070656

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K070656
Device Name Device, Neurovascular Embolization
Applicant MICROVENTION, INC.
75 COLUMBIA
ALISO VIEJO, CA 92656-1408 US
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Contact VINCENT CUTARELLI
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 03/09/2007
Decision Date 06/15/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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