FDA 510(k) Application Details - K031578

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K031578
Device Name Device, Neurovascular Embolization
Applicant MICRUS CORP.
610 PALOMAR AVENUE
MOUNTAIN VIEW, CA 94085 US
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Contact MARGARET WEBBER
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 05/20/2003
Decision Date 08/01/2003
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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