European Custom Manufacturing BV
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K080621 | FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 | April 29, 2008 |
| K033858 | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | July 12, 2004 |