The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Hysterosalpingography Set.
| Device ID | K842231 |
| 510k Number | K842231 |
| Device Name: | ACKRAD HYSTEROSALPINGOGRAPHY SET |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | ACKRAD LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-05 |
| Decision Date | 1984-09-19 |