FDA 510(k) Application Details - K152700

Device Classification Name Shunt, Central Nervous System And Components

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510(K) Number K152700
Device Name Shunt, Central Nervous System And Components
Applicant MEDTRONIC NEUROSURGERY
125 CREMONA DRIVE
GOLETA, CA 93117 US
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Contact Micah Schloss
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Regulation Number 882.5550

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Classification Product Code JXG
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Date Received 09/21/2015
Decision Date 04/07/2016
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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