510(k) K234050 · FRG Wrap, Sterilization
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap
| Applicant | O&M Halyard, Inc., Mechanicsville VA, US |
| Decision | Substantially Equivalent, Sep 16, 2024 |
| Received | Dec 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234050
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.