Product code
NOK: Material, external aesthetic restoration, no adhesive
FDA product code · Class I · General & Plastic Surgery
Key facts
| Product code | NOK |
|---|---|
| Device | Material, external aesthetic restoration, no adhesive |
| Device class | Class I |
| Regulation number | 878.3800 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| Definition | external aesthetic restoration prosthesis |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database