CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM


Device Classification Name

shunt, central nervous system and components

510(k) Number K112156
Device Name CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
Applicant
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham, 
MA 
02767

Applicant Contact jocelyn raposo
Correspondent
MEDOS INTERNATIONAL SARL
325 paramount drive
raynham, 
MA 
02767

Correspodent Contact jocelyn raposo
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 07/27/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls