| Proprietary Name: |
Inoue Balloon catheter |
| Classification Name: |
CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
| Product Code: |
MAD |
| Device Class: |
3 |
| Registered Establishment Name: |
TORAY INTERNATIONAL AMERICA INC.
|
| Registered Establishment Number: |
1649869
|
| Owner/Operator: |
TORAY INTERNATIONAL AMERICA INC. |
| Owner/Operator Number: |
2435106
|
| Establishment Operations: |
Repackager/Relabeler
|