510(k) K192147 ยท FRG Wrap, Sterilization
Halyard ONE-STEP* Sterilization Wrap
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Aug 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192147
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.