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
|
|
Correspondent Contact |
JOCELYN RAPOSO |
Regulation Number | 882.5550
|
Classification Product Code |
|
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
|
|
|