FDA 510(k) Application Details - K960037

Device Classification Name Clip, Aneurysm

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510(K) Number K960037
Device Name Clip, Aneurysm
Applicant MIZUHO AMERICA, INC.
123 BRIMBAL AVE.
BEVERLY, MA 01915 US
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Contact LISA A SCHWEITZER
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Regulation Number 882.5200

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Classification Product Code HCH
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Date Received 01/03/1996
Decision Date 02/05/1997
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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