Device Classification Name |
subsystem, water purification
|
510(k) Number |
K080703 |
Device Name |
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK |
Applicant |
4M VENTURES, INC. |
1415 HALSEY WAY |
SUITE 304 |
CARROLLTON,
TX
75007 -4455
|
|
Applicant Contact |
DENICE GALLAGHER |
Correspondent |
4M VENTURES, INC. |
1415 HALSEY WAY |
SUITE 304 |
CARROLLTON,
TX
75007 -4455
|
|
Correspondent Contact |
DENICE GALLAGHER |
Regulation Number | 876.5665
|
Classification Product Code |
|
Date Received | 03/12/2008 |
Decision Date | 06/02/2008 |
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
|
|
|