Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K141227 |
Device Name |
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX |
Applicant |
SOPHYSA SA |
25108 MARGUERITE PARKWAY, SUITE A-354 |
MISSION VIEJO,
CA
92692
|
|
Applicant Contact |
GUSTAVO KOBRIN |
Correspondent |
SOPHYSA SA |
25108 MARGUERITE PARKWAY, SUITE A-354 |
MISSION VIEJO,
CA
92692
|
|
Correspondent Contact |
GUSTAVO KOBRIN |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 05/12/2014 |
Decision Date | 04/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|