The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Hydrology 5000.
| Device ID | K955339 |
| 510k Number | K955339 |
| Device Name: | HYDROLOGY 5000 |
| Classification | Catheter, Irrigation |
| 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 | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-20 |
| Decision Date | 1996-03-13 |