510(k) K011055 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
| Applicant | Go Medical Industries Pty. , Ltd., Subiaco, Perth, AU |
| Decision | Substantially Equivalent, Jun 6, 2001 |
| Received | Apr 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011055
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.