Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K072093 |
Device Name |
PRISMAFLEX SYSTEM, VERSION 3.20 |
Applicant |
GAMBRO |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Applicant Contact |
THOMAS B DOWELL |
Correspondent |
GAMBRO |
10810 W. COLLINS AVE. |
LAKEWOOD,
CO
80215
|
|
Correspondent Contact |
THOMAS B DOWELL |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 07/30/2007 |
Decision Date | 02/01/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|