510(k) K112191 ยท KGN Wound Dressing With Animal-Derived Material(S)
HEALEX BIOSPONGE WOUND DRESSING
| Applicant | Bionova Medical, Inc., Alexandria VA, US |
| Decision | Substantially Equivalent, Jun 5, 2012 |
| Received | Jul 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112191
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.