| Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
|---|
| 510(K) Number |
K122347 |
|---|
| Models |
-110M,-130M,-150M,-170M,-190M,-210M,
-90H,-110H,-130H,-150H,-170H,-190H,-210H,250H
|
| Device Name |
ELISIO-H HEMODIALYZER |
|---|
| Applicant |
| NIPRO MEDICAL CORPORATION |
| 6695 river crest pt |
|
suwanee,
GA
30024
|
|
| Contact |
carolyn george |
| Regulation Number | 876.5860
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/03/2012 |
|---|
| Decision Date | 05/01/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
