The following data is part of a premarket notification filed by Universal Hydrotech, Inc. with the FDA for Systems Flow 2000.
| Device ID | K902993 |
| 510k Number | K902993 |
| Device Name: | SYSTEMS FLOW 2000 |
| Classification | Colonic Irrigation System |
| Applicant | UNIVERSAL HYDROTECH, INC. C/O CHARLES I. ROSE & CO, INC. 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose UNIVERSAL HYDROTECH, INC. C/O CHARLES I. ROSE & CO, INC. 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-09 |
| Decision Date | 1990-12-24 |