Device Classification Name |
Subsystem, Water Purification
|
510(k) Number |
K071104 |
Device Name |
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
Applicant |
FLIER'S QUALITY WATER SYSTEMS INC |
7425 CLYDE PARK AVENUE SW |
SUITE A |
BYRON CENTER,
MI
49315
|
|
Applicant Contact |
JAMES FLIER |
Correspondent |
FLIER'S QUALITY WATER SYSTEMS INC |
7425 CLYDE PARK AVENUE SW |
SUITE A |
BYRON CENTER,
MI
49315
|
|
Correspondent Contact |
JAMES FLIER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 04/19/2007 |
Decision Date | 01/14/2008 |
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
|
|
|