510(k) K082553 ยท OLR Oral Wound Dressing
REXASTOM ORAL EASE
| Applicant | Rexaderm, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Sep 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082553
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.