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 |