FDA 510(k) Application Details - K133625

Device Classification Name Guide, Wire, Catheter, Neurovasculature

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510(K) Number K133625
Device Name Guide, Wire, Catheter, Neurovasculature
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact HANNAH FOLEY
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Regulation Number 870.1330

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Classification Product Code MOF
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Date Received 11/26/2013
Decision Date 02/24/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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