FDA 510(k) Application Details - K103780

Device Classification Name Catheter, Intravascular Occluding, Temporary

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510(K) Number K103780
Device Name Catheter, Intravascular Occluding, Temporary
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 870.4450

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Classification Product Code MJN
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Date Received 12/27/2010
Decision Date 01/26/2011
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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