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FDA 510(k) Application Details - K143111
Device Classification Name
Shunt, Central Nervous System And Components
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.5550
More FDA Info for this Regulation Number
Classification Product Code
JXG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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