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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name external cerebrospinal fluid (csf) diversion
510(k) Number DEN120017
Device Name Medtronic DUET External Drainage and Monitoring System
Original Applicant
125 cremona dr.
goleta,  CA  93117
Original Contact donovan may
Regulation Number882.5560
Classification Product Code
Date Received12/21/2012
Decision Date 08/22/2014
Decision granted (DENG)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Post-NSE
Reviewed by Third Party No
Combination Product No