510(k) K182830 ยท QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
| Applicant | Cardinal Health200, LLC, Waukegan IL, US |
| Decision | Substantially Equivalent, Apr 26, 2019 |
| Received | Oct 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182830
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.