Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K090342 |
Device Name |
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 |
Applicant |
SOPHYSA SA |
2884 DANAPOPLAR |
DANA POINT,
CA
92629
|
|
Applicant Contact |
ESTHER SALTZ |
Correspondent |
SOPHYSA SA |
2884 DANAPOPLAR |
DANA POINT,
CA
92629
|
|
Correspondent Contact |
ESTHER SALTZ |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 02/10/2009 |
Decision Date | 08/11/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|