De Novo
DEN070002: QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
FDA De Novo · quick-med technologies, inc. · decided Feb 25, 2009
Key facts
| De Novo number | DEN070002 |
|---|---|
| Device name | QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING |
| Applicant | quick-med technologies, inc. |
| Product code | NYS |
| Date received | May 10, 2007 |
| Decision date | Feb 25, 2009 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
| FEI number | 3030531253 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: