Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K153329 |
Device Name |
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis |
Applicant |
MED-TECH WATER SYSTEMS INC |
1755 WOOLNER AVENUE SUITE B |
FAIRFIELD,
CA
94533
|
|
Applicant Contact |
BRIAN C KIM |
Correspondent |
MED-TECH WATER SYSTEMS INC |
1755 WOOLNER AVENUE SUITE B |
FAIRFIELD,
CA
94533
|
|
Correspondent Contact |
BRIAN C KIM |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 11/19/2015 |
Decision Date | 08/04/2016 |
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
|
|
|