FDA 510(k) Application Details - K143111

Device Classification Name Shunt, Central Nervous System And Components

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510(K) Number K143111
Device Name Shunt, Central Nervous System And Components
Applicant MEDOS INTERNATIONAL SARL
CHEMIN-BLANC 38
LE LOCLE 2400 CH
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Contact Michelle Godin
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Regulation Number 882.5550

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Classification Product Code JXG
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Date Received 10/29/2014
Decision Date 02/19/2015
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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