Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K011221 |
Device Name |
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET |
Applicant |
GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
SUZANNE DENNIS |
Correspondent |
GAMBRO RENAL PRODUCTS |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
SUZANNE DENNIS |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 04/20/2001 |
Decision Date | 10/31/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|