Device Classification Name |
subsystem, water purification
|
510(k) Number |
K102892 |
Device Name |
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS |
Applicant |
AQUA SCIENCES, INC. |
565 FILLMORE AVENUE |
TONAWANDA,
NY
14150
|
|
Applicant Contact |
MICHAEL J TODD |
Correspondent |
AQUA SCIENCES, INC. |
565 FILLMORE AVENUE |
TONAWANDA,
NY
14150
|
|
Correspondent Contact |
MICHAEL J TODD |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 09/30/2010 |
Decision Date | 02/03/2011 |
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
|
|
|