510(k) K063517 ยท FRO Dressing, Wound, Drug
HEALADEX-P
| Applicant | Healagenics, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Feb 16, 2007 |
| Received | Nov 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063517
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.