Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K855058 |
Device Name |
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID |
Applicant |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Applicant Contact |
DAVID KORNHAUSER |
Correspondent |
CORDIS CORP. |
P.O. BOX 025700 |
MIAMI,
FL
33102
|
|
Correspondent Contact |
DAVID KORNHAUSER |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 12/18/1985 |
Decision Date | 01/10/1986 |
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
|
|
|