510(k) K181478 ยท FRO Dressing, Wound, Drug
Roosin Xeroform Petrolatum Dressing
| Applicant | Roosin Medical Co., Ltd., Taizhou, CN |
| Decision | Substantially Equivalent, Sep 13, 2019 |
| Received | Jun 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181478
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.