Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K131381 |
Device Name |
ELISIO-H HEMODIALYZER |
Applicant |
NIPRO MEDICAL CORPORATION |
6695 RIVER CREST PT |
SUWANEE,
GA
30024
|
|
Applicant Contact |
CAROLYN GEORGE |
Correspondent |
NIPRO MEDICAL CORPORATION |
6695 RIVER CREST PT |
SUWANEE,
GA
30024
|
|
Correspondent Contact |
CAROLYN GEORGE |
Regulation Number | 876.5860
|
Classification Product Code |
|
Date Received | 05/14/2013 |
Decision Date | 12/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|