510(k) K131286 ยท KGN Wound Dressing With Animal-Derived Material(S)
PRIMATRIX DERMAL REPAIR SCAFFOLD
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Aug 5, 2013 |
| Received | May 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131286
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.