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FDA 510(k) Application Details - K110560
Device Classification Name
Shunt, Central Nervous System And Components
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510(K) Number
K110560
Device Name
Shunt, Central Nervous System And Components
Applicant
MEDTRONIC NEUROSURGERY
125 CREMONA DR.
GOLETA, CA 93117 US
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Contact
JEFFREY HENDERSON
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Regulation Number
882.5550
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Classification Product Code
JXG
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More FDA Info for this Product Code
Date Received
02/28/2011
Decision Date
11/18/2011
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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