510(k) K201138 · FRO Dressing, Wound, Drug
AMSure® Single Use Saline Topical Solution
| Applicant | Amsino Medical, Inc., Aurora IL, US |
| Decision | Substantially Equivalent, Apr 14, 2021 |
| Received | Apr 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201138
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.