Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K902783 |
Device Name |
PS MEDICAL DELTA CSF-FLOW CONTROL VALVE |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
P.O. BOX 2090 |
GOLETA,
CA
93118
|
|
Applicant Contact |
STEPHEN LAGUETTE |
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
P.O. BOX 2090 |
GOLETA,
CA
93118
|
|
Correspondent Contact |
STEPHEN LAGUETTE |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 06/26/1990 |
Decision Date | 08/08/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|