510(k) K083440 ยท KGN Wound Dressing With Animal-Derived Material(S)
PRIMATRIX DERMAL REPAIR SCAFFOLD
| Applicant | Tei Biosciences, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Dec 12, 2008 |
| Received | Nov 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083440
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.