510(k) K083024 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
HYLATOPIC EMOLLIENT FOAM
| Applicant | Collegium Pharmaceutical Incorporated, Cumberland RI, US |
| Decision | Substantially Equivalent, Mar 27, 2009 |
| Received | Oct 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083024
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.