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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shunt, central nervous system and components
510(k) Number K113526
Model 82-8800, 82-8801, 82-8002, 82-8804, 82-8805, 82-8806
Device Name CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
Original Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham,  MA  02767
Original Contact jocelyn raposo
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/30/2011
Decision Date 02/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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