Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K030592 |
Device Name |
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H |
Applicant |
GAMBRO RENAL CARE PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
JEFFREY R SCHIDMAN |
Correspondent |
GAMBRO RENAL CARE PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
JEFFREY R SCHIDMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/25/2003 |
Decision Date | 05/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|