Device Classification Name |
Dialyzer, High Permeability With Or Without Sealed Dialysate System
|
510(k) Number |
K003023 |
Device Name |
COBE HC 700 MIDI HEMOCONCENTRATOR |
Applicant |
HOSPAL INDUSTRIE |
14401 W. 65th Way |
Arvada,
CO
80004 -3599
|
|
Applicant Contact |
BARBARA A WATSON |
Correspondent |
HOSPAL INDUSTRIE |
14401 W. 65th Way |
Arvada,
CO
80004 -3599
|
|
Correspondent Contact |
BARBARA A WATSON |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 09/28/2000 |
Decision Date | 04/30/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|