510(k) K970133 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
AMERIGEL OINTMENT
| Applicant | Amerx Health Care Corp., Clearwater FL, US |
| Decision | Substantially Equivalent for Some Indications, Apr 14, 1997 |
| Received | Jan 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970133
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2016 | Amerx Health Care Corp. Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Terminated |
KMJ | None listed |
| Jun 12, 2015 | Amerx Health Care Corp. Amerigel Hydrogel Gauze Dressing 2 x 2, A5002.
Wound Management. Terminated |
MGQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.