510(k) K193085 ยท FRO Dressing, Wound, Drug
PuraDERM Gel
| Applicant | 3-D Matrix, Inc., Needham MA, US |
| Decision | Substantially Equivalent, May 11, 2020 |
| Received | Nov 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193085
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.