Device Classification Name |
apparatus, hemoperfusion, sorbent
|
510(k) Number |
K984546 |
Device Name |
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK |
Applicant |
HEMOCLEANSE, INC. |
2700 KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Applicant Contact |
STEPHEN R ASH |
Correspondent |
HEMOCLEANSE, INC. |
2700 KENT AVE. |
WEST LAFAYETTE,
IN
47906
|
|
Correspondent Contact |
STEPHEN R ASH |
Regulation Number | 876.5870
|
Classification Product Code |
|
Date Received | 12/22/1998 |
Decision Date | 08/13/1999 |
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
|
|
|