510(k) K120828 ยท FRO Dressing, Wound, Drug
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
| Applicant | Coloplast A/S, Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 5, 2012 |
| Received | Mar 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120828
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.