The following data is part of a premarket notification filed by U.s. Filter/continental Water Systems with the FDA for Submersible Reverse Osmosis Water Purification Sys.
| Device ID | K894300 |
| 510k Number | K894300 |
| Device Name: | SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS |
| Classification | Subsystem, Water Purification |
| Applicant | U.S. FILTER/CONTINENTAL WATER SYSTEMS 5405 BANDERA RD., SUITE 101 San Antonio, TX 78238 |
| Contact | Linda Stewart |
| Correspondent | Linda Stewart U.S. FILTER/CONTINENTAL WATER SYSTEMS 5405 BANDERA RD., SUITE 101 San Antonio, TX 78238 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-22 |
| Decision Date | 1990-03-13 |