The following data is part of a premarket notification filed by Gomedical Industries Pty Ltd. with the FDA for Aspirating And Irrigating Cysts Needles.
| Device ID | K885283 |
| 510k Number | K885283 |
| Device Name: | ASPIRATING AND IRRIGATING CYSTS NEEDLES |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | GOMEDICAL INDUSTRIES PTY LTD. 20, DENIS ST. SUBIACO 6008 Western Australia, AU |
| Contact | George O'neil |
| Correspondent | George O'neil GOMEDICAL INDUSTRIES PTY LTD. 20, DENIS ST. SUBIACO 6008 Western Australia, AU |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-20 |
| Decision Date | 1989-03-22 |