Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K923727 |
Device Name |
PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 |
Applicant |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
LEROY FISHBACH |
Correspondent |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
LEROY FISHBACH |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 07/27/1992 |
Decision Date | 07/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|