Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K161304 |
Device Name |
EndoPur Filter |
Applicant |
Nephros Inc. |
41 Grand Ave |
River Edge,
NJ
07661
|
|
Applicant Contact |
Hollie Johnson |
Correspondent |
Nephros Inc. |
41 Grand Ave |
River Edge,
NJ
07661
|
|
Correspondent Contact |
Hollie Johnson |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 05/10/2016 |
Decision Date | 03/02/2017 |
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
|
|
|