510(k) K082865 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
MODIFICATION TO ZENIEVA
| Applicant | Gorbec Pharmaceutical Services, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Oct 23, 2008 |
| Received | Sep 29, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082865
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.