The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for The O'neil Sterile Field Urinary Catheter Kit With Prep Pads.
| Device ID | K011055 |
| 510k Number | K011055 |
| Device Name: | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| 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 | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-06-06 |