Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K924437 |
Device Name |
HEMOSPAL KIT B22 / MULTIFLOW 60 KIT |
Applicant |
C.G.H. MEDICAL, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
VERA BUFFALOE |
Correspondent |
C.G.H. MEDICAL, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
VERA BUFFALOE |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/01/1992 |
Decision Date | 06/27/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|