Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K903844 |
Device Name |
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING |
Applicant |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Applicant Contact |
MARVIN L SUSSMAN |
Correspondent |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Correspondent Contact |
MARVIN L SUSSMAN |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 08/21/1990 |
Decision Date | 12/28/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|