Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K182265 |
Device Name |
CodMan Certas Plus Programmable Valve |
Applicant |
Integra LifeSciences Corp. |
11 Cabot Blvd |
Mansfield,
MA
02048
|
|
Applicant Contact |
Nancy MacDonald |
Correspondent |
Integra LifeSciences Corp. |
11 Cabot Blvd |
Mansfield,
MA
02048
|
|
Correspondent Contact |
Nancy MacDonald |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 08/21/2018 |
Decision Date | 11/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|