510(k) K182010 ยท KGN Wound Dressing With Animal-Derived Material(S)
ProgenaMatrix
| Applicant | Cell Constructs I, LLC, Woodstock GA, US |
| Decision | Substantially Equivalent, Jan 17, 2019 |
| Received | Jul 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2022 | ProgenaCare progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm. Terminated |
KGN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.