The following data is part of a premarket notification filed by G.e.m. Water Systems with the FDA for Reverse Osmosis System.
| Device ID | K944493 |
| 510k Number | K944493 |
| Device Name: | REVERSE OSMOSIS SYSTEM |
| Classification | Subsystem, Water Purification |
| 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 | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1996-02-20 |