The following data is part of a premarket notification filed by Gomedical Industries Pty Ltd. with the FDA for Amniglove & Amnicot.
| Device ID | K850758 |
| 510k Number | K850758 |
| Device Name: | AMNIGLOVE & AMNICOT |
| Classification | Amniotome |
| 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 | HGE |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-04-15 |