| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K091042 |
| Device Name |
CRONO S-PID 50 |
| Applicant |
| Cane S.R.L. |
| Via Pavia, 105/I 10090 |
|
Rivoli-Cascine Vica (Torino),
IT
|
|
| Applicant Contact |
CARLO MUSSO |
| Correspondent |
| Cane S.R.L. |
| Via Pavia, 105/I 10090 |
|
Rivoli-Cascine Vica (Torino),
IT
|
|
| Correspondent Contact |
CARLO MUSSO |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 04/13/2009 |
| Decision Date | 05/12/2009 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Summary |
Summary
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|