510(k) K131796 ยท FRO Dressing, Wound, Drug
MANUKA FILL WOUND DRESSING
| Applicant | Links Medical Products, Inc., Laguna Niguel CA, US |
| Decision | Substantially Equivalent, Mar 14, 2014 |
| Received | Jun 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel Open, Classified |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.