Device Classification Name |
subsystem, water purification
|
510(k) Number |
K022747 |
Device Name |
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM |
Applicant |
HYDROPURE SYSTEMS, INC. |
3319 BARTLETT BLVD. |
ORLANDO,
FL
32817
|
|
Applicant Contact |
ROBERT V PRICE |
Correspondent |
HYDROPURE SYSTEMS, INC. |
3319 BARTLETT BLVD. |
ORLANDO,
FL
32817
|
|
Correspondent Contact |
ROBERT V PRICE |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 08/19/2002 |
Decision Date | 02/11/2003 |
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
|
|
|