510(k) K161289 ยท FRO Dressing, Wound, Drug
DURAFIBER Ag
| Applicant | Smith & Nephew Medical Limited, Hull, GB |
| Decision | Substantially Equivalent, Aug 3, 2016 |
| Received | May 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161289
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.