The following data is part of a premarket notification filed by G.e.m. Water Systems with the FDA for G.e.m. Water Systems, International.
| Device ID | K970674 |
| 510k Number | K970674 |
| Device Name: | G.E.M. WATER SYSTEMS, INTERNATIONAL |
| Classification | Tank, Holding, Dialysis |
| Applicant | G.E.M. WATER SYSTEMS 5940 LAKESHORE DR. Cypress, CA 90630 |
| Contact | Jack Enkowitz |
| Correspondent | Jack Enkowitz G.E.M. WATER SYSTEMS 5940 LAKESHORE DR. Cypress, CA 90630 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-24 |
| Decision Date | 1997-11-19 |