The following data is part of a premarket notification filed by Aqua-med Systems, Inc. with the FDA for Service Deionization Syst/di Tank Exchange Program.
Device ID | K915258 |
510k Number | K915258 |
Device Name: | SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM |
Classification | Subsystem, Water Purification |
Applicant | AQUA-MED SYSTEMS, INC. 3607 CHAPEL HILL ROAD, SUITE M Mchenry, IL 60050 |
Contact | Thomas W Huemann |
Correspondent | Thomas W Huemann AQUA-MED SYSTEMS, INC. 3607 CHAPEL HILL ROAD, SUITE M Mchenry, IL 60050 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-19 |
Decision Date | 1993-07-02 |