The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for Modified Urinary Catheter Introducer (uci).
| Device ID | K890400 |
| 510k Number | K890400 |
| Device Name: | MODIFIED URINARY CATHETER INTRODUCER (UCI) |
| Classification | Catheter, Urological |
| Applicant | GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Contact | George O'neil |
| Correspondent | George O'neil GO MEDICAL INDUSTRIES PTY. LTD. 200 CHURCHILL AVE. Subiaco, Perth, AU 6008 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-24 |
| Decision Date | 1989-09-12 |