510(k) K000051 ยท FRO Dressing, Wound, Drug
ACTICOAT FOAM DRESSING
| Applicant | Westaim Biomedical, Inc., Exeter NH, US |
| Decision | Substantially Equivalent, Apr 5, 2000 |
| Received | Jan 7, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2003 | Smith And Nephew, Inc. Wound Management Division Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.