The following data is part of a premarket notification filed by Nortech with the FDA for 7-510-25 Hysteromed Tubing Kit.
| Device ID | K931606 |
| 510k Number | K931606 |
| Device Name: | 7-510-25 HYSTEROMED TUBING KIT |
| Classification | Insufflator, Hysteroscopic |
| Applicant | NORTECH 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Kenneth J Sikora |
| Correspondent | Kenneth J Sikora NORTECH 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 | 1993-04-01 |
| Decision Date | 1994-01-24 |