Device Classification Name |
subsystem, water purification
|
510(k) Number |
K033648 |
Device Name |
PERFORMANCE WATER TREATMENT SYSTEM |
Applicant |
PERFORMANCE WATER SYSTEMS, LLC |
13601 SOUTH KENTON AVE. |
CRESTWOOD,
IL
60445
|
|
Applicant Contact |
ROBERT DOWNEY |
Correspondent |
PERFORMANCE WATER SYSTEMS, LLC |
13601 SOUTH KENTON AVE. |
CRESTWOOD,
IL
60445
|
|
Correspondent Contact |
ROBERT DOWNEY |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 11/20/2003 |
Decision Date | 08/09/2004 |
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
|
|
|