510(k) K964468 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
IAMIN WET DRESSING (COPPER-SALINE)
| Applicant | Procyte Corp., Kirkland WA, US |
| Decision | Substantially Equivalent, Feb 3, 1997 |
| Received | Nov 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | PhotoMedex, Inc. Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination Terminated |
MGQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.