510(k) K070048 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT
| Applicant | Marian Medical, Inc., Louisville KY, US |
| Decision | Substantially Equivalent, Mar 15, 2007 |
| Received | Jan 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070048
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.