Device Classification Name |
shunt, central nervous system and components |
|||
---|---|---|---|---|
510(k) Number | K122118 | |||
Device Name | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | |||
Applicant |
|
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Applicant Contact | kathy strange | |||
Correspondent |
|
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Correspodent Contact | kathy strange | |||
Regulation Number | 882.5550 | |||
Classification Product Code |
|
|||
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 |