Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K070320 |
Device Name |
EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 |
Applicant |
EDWARDS LIFESCIENCES SERVICES GMBH |
BUSINESS & TECHNOLOGY CENTER |
BESSEMER DRIVE |
STEVENAGE, HERTSFORDSHIRE,
GB
SG1 2DX
|
|
Applicant Contact |
NEIL R ARMSTRONG |
Correspondent |
EDWARDS LIFESCIENCES SERVICES GMBH |
BUSINESS & TECHNOLOGY CENTER |
BESSEMER DRIVE |
STEVENAGE, HERTSFORDSHIRE,
GB
SG1 2DX
|
|
Correspondent Contact |
NEIL R ARMSTRONG |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 02/02/2007 |
Decision Date | 06/07/2007 |
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
|
|
|