The following data is part of a premarket notification filed by Go Medical Industries Pty. Ltd. with the FDA for Go Medical Balloon Infusion System.
| Device ID | K000263 |
| 510k Number | K000263 |
| Device Name: | GO MEDICAL BALLOON INFUSION SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| 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 | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-28 |
| Decision Date | 2000-05-09 |