The following data is part of a premarket notification filed by Gomedical Industries Pty Ltd. with the FDA for O'neil Obstetric Cup.
| Device ID | K840008 |
| 510k Number | K840008 |
| Device Name: | O'NEIL OBSTETRIC CUP |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | GOMEDICAL INDUSTRIES PTY LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-04 |
| Decision Date | 1984-04-25 |