Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K852885 |
Device Name |
FILTRAL HEMODIALYZER |
Applicant |
HOSPAL MEDICAL CORP. |
25 KIMBERLY RD. |
P.O. BOX 857 |
EAST BRUNSWICK,
NJ
08816
|
|
Applicant Contact |
DOUGLAS L VLCHEK |
Correspondent |
HOSPAL MEDICAL CORP. |
25 KIMBERLY RD. |
P.O. BOX 857 |
EAST BRUNSWICK,
NJ
08816
|
|
Correspondent Contact |
DOUGLAS L VLCHEK |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 07/09/1985 |
Decision Date | 09/06/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|