The following data is part of a premarket notification filed by 4m Ventures, Inc. with the FDA for Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank.
Device ID | K080703 |
510k Number | K080703 |
Device Name: | BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK |
Classification | Subsystem, Water Purification |
Applicant | 4M VENTURES, INC. 1415 HALSEY WAY SUITE 304 Carrollton, TX 75007 -4455 |
Contact | Denice Gallagher |
Correspondent | Denice Gallagher 4M VENTURES, INC. 1415 HALSEY WAY SUITE 304 Carrollton, TX 75007 -4455 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-12 |
Decision Date | 2008-06-02 |
Summary: | summary |