Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K955487 |
Device Name |
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS |
Applicant |
COBE RENAL CARE, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4407
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
COBE RENAL CARE, INC. |
1185 OAK ST. |
LAKEWOOD,
CO
80215 -4407
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 12/01/1995 |
Decision Date | 04/18/1997 |
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
|
|
|