Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K934545 |
Device Name |
PS MEDICAL DELTA BURR HOLE VALVE |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
UNIVERSITY BUSINESS CENTER |
125-B CREMONA DRIVE |
GOLETA,
CA
93117
|
|
Applicant Contact |
TOM HOLDYCH |
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
UNIVERSITY BUSINESS CENTER |
125-B CREMONA DRIVE |
GOLETA,
CA
93117
|
|
Correspondent Contact |
TOM HOLDYCH |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 09/22/1993 |
Decision Date | 04/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|