CSF400 AND CSF600


Device Classification Name

shunt, central nervous system and components

510(k) Number K030081
Device Name CSF400 AND CSF600
Original Applicant
INMED LTDA.
1308 morningside park dr.
alpharetta, 
GA 
30022

Original Contact jay mansour
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 01/09/2003
Decision Date 10/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No