| Device Classification Name |
Shunt, Central Nervous System And Components
|
| 510(k) Number |
K920156 |
| Device Name |
CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY |
| Applicant |
| Clinical Neuro Systems, LLC |
| 870 Serenidad Pl. |
|
Goleta,
CA
93117
|
|
| Applicant Contact |
STEPHEN W LAGUETTE |
| Correspondent |
| Clinical Neuro Systems, LLC |
| 870 Serenidad Pl. |
|
Goleta,
CA
93117
|
|
| Correspondent Contact |
STEPHEN W LAGUETTE |
| Regulation Number | 882.5550 |
| Classification Product Code |
|
| Date Received | 01/14/1992 |
| Decision Date | 03/16/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
| Recalls |
CDRH Recalls
|
|
|