510(k) K193583 · QSZ Absorbable Synthetic Wound Dressing
Restrata®
| Applicant | Acera Surgical, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 25, 2020 |
| Received | Dec 23, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193583
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2022 | Acera Surgical Inc Restrata, Part Number RWM1-2X2 Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.