510(k) K123394 ยท FRO Dressing, Wound, Drug
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
| Applicant | Coreleader Biotech Co., Ltd., New Taipei, Taiwan, TW |
| Decision | Substantially Equivalent, Jun 6, 2013 |
| Received | Nov 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123394
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.