Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K060008 |
Device Name |
AQUADEX FLEXFLOW SYSTEM |
Applicant |
CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 |
BROOKLYN PARK,
MN
55428
|
|
Applicant Contact |
CHRIS SCAVOTTO |
Correspondent |
CHF SOLUTIONS, INC. |
7601 NORTHLAND DR. STE. 170 |
BROOKLYN PARK,
MN
55428
|
|
Correspondent Contact |
CHRIS SCAVOTTO |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 01/03/2006 |
Decision Date | 02/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|