The following data is part of a premarket notification filed by Humi Corp. with the FDA for Uterine Injector 4.0mm.
| Device ID | K841682 |
| 510k Number | K841682 |
| Device Name: | UTERINE INJECTOR 4.0MM |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | HUMI CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-07-03 |