Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K924600 |
Device Name |
INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS |
Applicant |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
MARVIN L SUSSMAN |
Correspondent |
CORDIS CORP. |
14201 N.W. 60TH AVE. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
MARVIN L SUSSMAN |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 09/11/1992 |
Decision Date | 12/10/1992 |
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
|
|
|