FDA 510(k) Application Details - DEN120017

Device Classification Name

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510(K) Number DEN120017
Device Name Medtronic DUET External Drainage and Monitoring System
Applicant MEDTRONIC NEUROSURGERY
125 CREMONA DR.
GOLETA, CA 93117 US
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Contact DONOVAN MAY
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Regulation Number

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Classification Product Code PCB
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Date Received 12/21/2012
Decision Date 08/22/2014
Decision DENG -
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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