Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K071298 |
Device Name |
HF JUNIOR HEMOFILTER |
Applicant |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
LYNN LUEDERS |
Correspondent |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
LYNN LUEDERS |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/09/2007 |
Decision Date | 08/08/2007 |
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
|
|
|