510(k) K112399 ยท KGN Wound Dressing With Animal-Derived Material(S)
UNITE BIOMATRIX
| Applicant | Synovis Orthopedic & Woundcare, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 7, 2011 |
| Received | Aug 19, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112399
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.