510(k) K053095 ยท FRO Dressing, Wound, Drug
HONEY ALGINATE DRESSING
| Applicant | Derma Sciences Canada, Inc., Toronto, Orntario, CA |
| Decision | Substantially Equivalent, Jul 12, 2007 |
| Received | Nov 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045.
MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autoly Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.