De Novo
DEN090005: PRINEO SKIN CLOSURE SYSTEM
FDA De Novo · closure medical corp. · decided Apr 30, 2010
Key facts
| De Novo number | DEN090005 |
|---|---|
| Device name | PRINEO SKIN CLOSURE SYSTEM |
| Applicant | closure medical corp. |
| Product code | OMD |
| Date received | Mar 24, 2009 |
| Decision date | Apr 30, 2010 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General & Plastic Surgery |
At a glance
- 1–9 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: