The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Vapor-tech Sled Electrode.
| Device ID | K970717 |
| 510k Number | K970717 |
| Device Name: | VAPOR-TECH SLED ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, 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 | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-27 |
| Decision Date | 1997-05-08 |
| Summary: | summary |