Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K081942 |
FOIA Releasable 510(k) |
K081942
|
Device Name |
NEUROCATH AG |
Applicant |
VYGON NEURO |
2495 GENERAL ARMISTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
VYGON NEURO |
2495 GENERAL ARMISTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 07/08/2008 |
Decision Date | 08/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|