510(k) K010583 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
AMBU GEL, HYDROGEL BURN DRESSING
| Applicant | Ambu, Inc., Linthicum MD, US |
| Decision | Substantially Equivalent, May 25, 2001 |
| Received | Feb 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010583
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.