HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM


Device Classification Name

shunt, central nervous system and components

510(k) Number K122118
Device Name HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Applicant
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Applicant Contact kathy strange
Correspondent
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Correspodent Contact kathy strange
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 07/17/2012
Decision Date 08/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No