The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Hysteromed 100.
| Device ID | K930912 |
| 510k Number | K930912 |
| Device Name: | HYSTEROMED 100 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Kenneth Sikora |
| Correspondent | Kenneth Sikora NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-22 |
| Decision Date | 1994-10-17 |