The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Northgate Flow Assist Tubing For Urology.
| Device ID | K943361 |
| 510k Number | K943361 |
| Device Name: | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY |
| Classification | System, Irrigation, Urological |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Casey Kurek |
| Correspondent | Casey Kurek NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1995-09-29 |