Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K161992 |
Device Name |
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems |
Applicant |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
JENNIFER SIEGEL |
Correspondent |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
JENNIFER SIEGEL |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 07/19/2016 |
Decision Date | 09/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|