617014
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |