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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 K122118
Device Name HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Original Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham,  MA  02767 0350
Original Contact kathy strange
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/17/2012
Decision Date 08/03/2012
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
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