510(k) K183015 ยท NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
PuraSinus
| Applicant | 3-D Matrix, Inc., Needham MA, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Oct 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2019 | 3-D Matrix, Inc. PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 Terminated |
NHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.