The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Hydrotower Management System, Model 4-750-00.
| Device ID | K993778 |
| 510k Number | K993778 |
| Device Name: | HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 2000-01-06 |
| Summary: | summary |