BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK


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

Correspodent Contact denice gallagher
Regulation Number 876.5665
Classification Product Code
FIP  
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