Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K883307 |
Device Name |
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT |
Applicant |
HOSPAL MEDICAL CORP. |
21 NORTHFIELD AVE. |
RARITAN CENTER |
EDISON,
NJ
08837
|
|
Applicant Contact |
CATHERINA MADORMO |
Correspondent |
HOSPAL MEDICAL CORP. |
21 NORTHFIELD AVE. |
RARITAN CENTER |
EDISON,
NJ
08837
|
|
Correspondent Contact |
CATHERINA MADORMO |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 08/04/1988 |
Decision Date | 10/12/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|