The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for Single Lumen O'neil Aspiration & Irrigation Needle.
| Device ID | K895594 |
| 510k Number | K895594 |
| Device Name: | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Contact | Agb O'neil |
| Correspondent | Agb O'neil GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1989-10-06 |