The following data is part of a premarket notification filed by Axcan Scientific Corp. with the FDA for Axcan Sperm Cup.
| Device ID | K831669 |
| 510k Number | K831669 |
| Device Name: | AXCAN SPERM CUP |
| Classification | Cap, Cervical |
| Applicant | AXCAN SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-07-12 |