FDA 510(k) Application Details - K060915

Device Classification Name Clip, Aneurysm

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510(K) Number K060915
Device Name Clip, Aneurysm
Applicant KIRWAN SURGICAL PRODUCTS, INC.
180 ENTERPRISE DRIVE
MARSHFIELD, MA 02050 US
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Contact KEVIN P PRARIO
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Regulation Number 882.5200

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Classification Product Code HCH
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Date Received 04/04/2006
Decision Date 04/17/2007
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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