| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K850997 |
| Device Name |
UVP 2000 VOLUMED -TENTATIVE |
| Applicant |
| Sterling Medical Devices, Inc. |
| 1616 W. Shaw Ave. |
| Suite D-1 |
|
Fresno,
CA
93711
|
|
| Applicant Contact |
FRANK FERGUSON |
| Correspondent |
| Sterling Medical Devices, Inc. |
| 1616 W. Shaw Ave. |
| Suite D-1 |
|
Fresno,
CA
93711
|
|
| Correspondent Contact |
FRANK FERGUSON |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 03/11/1985 |
| Decision Date | 05/13/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|