510(k) K153138 ยท FRO Dressing, Wound, Drug
Cerdak Basic
| Applicant | Bu Polysciences Equipment & Trading, LLC, North Bethesda MD, US |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Oct 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153138
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.