Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K983085 |
Device Name |
HEMOCOR HPH 700 HEMOCONCENTRATOR |
Applicant |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
MARK MURPHY |
Correspondent |
MINNTECH CORP. |
14605 28TH AVE. NORTH |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
MARK MURPHY |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/03/1998 |
Decision Date | 11/13/1998 |
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
|
|
|