Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K092481 |
Device Name |
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 |
Applicant |
NEW AQUA LLC (DBA AQUA SYSTEMS) |
114 VISTA PARKWAY |
AVON,
IN
46123
|
|
Applicant Contact |
NEVIN RUDIE |
Correspondent |
NEW AQUA LLC (DBA AQUA SYSTEMS) |
114 VISTA PARKWAY |
AVON,
IN
46123
|
|
Correspondent Contact |
NEVIN RUDIE |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 08/13/2009 |
Decision Date | 04/02/2010 |
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
|
|
|