The following data is part of a premarket notification filed by C. Intl. with the FDA for Vagi-press #401.
| Device ID | K790851 |
| 510k Number | K790851 |
| Device Name: | VAGI-PRESS #401 |
| Classification | Instrument, Manual, General Obstetric-gynecologic |
| Applicant | C. INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOH |
| CFR Regulation Number | 884.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-04 |
| Decision Date | 1979-07-30 |