510(k) K983163 ยท FRO Dressing, Wound, Drug
BIATAIN FOAM DRESSING
| Applicant | Coloplast Corp., Marietta GA, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Sep 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983163
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.