510(k) K181959 ยท FRG Wrap, Sterilization
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
| Applicant | Owens & Minor Halyard, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Mar 22, 2019 |
| Received | Jul 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181959
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.