510(k) K961442 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
UNIVERSAL DRAINAGE TRAY
| Applicant | Customed, Inc., Fajardo PR, US |
| Decision | Substantially Equivalent, May 9, 1996 |
| Received | Apr 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Customed, Inc Universal drainage kit, catalog# 900-032 Terminated |
FCM | None listed |
| Mar 21, 2012 | Customed, Inc Urethral Catheter Tray catalog# 900-278 Terminated |
FCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.