510(k) K083721 ยท NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic
MODIFICATION TO ZENIEVA
| Applicant | River'S Edge Pharmaceuticals, LLC, Durham NC, US |
| Decision | Substantially Equivalent, Jan 8, 2009 |
| Received | Dec 15, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083721
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.