510(k) K100218 ยท FRO Dressing, Wound, Drug
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Feb 17, 2010 |
| Received | Jan 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100218
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.