Device Classification Name |
instrument, shunt system implantation
|
510(k) Number |
K930606 |
Device Name |
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
125-B CREMONA DR. |
GOLETA,
CA
93117
|
|
Applicant Contact |
TOM HOLDYCH |
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
125-B CREMONA DR. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
TOM HOLDYCH |
Regulation Number | 882.4545
|
Classification Product Code |
|
Date Received | 02/05/1993 |
Decision Date | 09/10/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|