510(k) K202000 ยท OLR Oral Wound Dressing
Silatrix Oral Gel
| Applicant | Sa3, LLC, Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 20, 2020 |
| Received | Jul 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202000
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2022 | SA3, LLC Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm Terminated |
OLR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.