FDA 510(k) Application Details - K142429

Device Classification Name Device, Neurovascular Embolization

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510(K) Number K142429
Device Name Device, Neurovascular Embolization
Applicant Codman & Shurtleff, Inc
325 Paramount Drive
Raynham, MA 02767 US
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Contact Hannah Foley
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Regulation Number 882.5950

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Classification Product Code HCG
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Date Received 08/29/2014
Decision Date 12/24/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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