FDA 510(k) Application Details - K102818

Device Classification Name Wire, Guide, Catheter

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510(K) Number K102818
Device Name Wire, Guide, Catheter
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 870.1330

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Classification Product Code DQX
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Date Received 09/28/2010
Decision Date 12/03/2010
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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