510(k) K143335 ยท FRO Dressing, Wound, Drug
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
| Applicant | Roosin Medical Devices Co., Ltd., Taizhou, CN |
| Decision | Substantially Equivalent, Jun 1, 2015 |
| Received | Nov 20, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143335
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.