510(k) K214007 ยท FRG Wrap, Sterilization
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
| Applicant | Owens & Minor (O&M) Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Jul 27, 2022 |
| Received | Dec 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214007
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.