The following data is part of a premarket notification filed by Axcan Scientific Corp. with the FDA for Axcan Uterine Succion Injector.
| Device ID | K842943 |
| 510k Number | K842943 |
| Device Name: | AXCAN UTERINE SUCCION INJECTOR |
| Classification | Insufflator, Hysteroscopic |
| Applicant | AXCAN SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-25 |
| Decision Date | 1984-09-21 |