The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Flo Assistant, Model 4-250-00.
| Device ID | K001325 |
| 510k Number | K001325 |
| Device Name: | FLO ASSISTANT, MODEL 4-250-00 |
| Classification | System, Irrigation, Urological |
| 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 | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-08-18 |