510(k) K780032 ยท FAQ Bag, Urine Collection, Leg, For External Use, Sterile
URINARY LEG BAG
| Applicant | C.R. Bard, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 17, 1978 |
| Received | Jan 9, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2003 | C.R. Bard, Inc., Urological Division Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, C.R.Bard, Inc., Covington, GA 30014, Contents Sterile. Terminated |
FAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.