| Device Classification Name |
Set, I.V. Fluid Transfer
|
| 510(k) Number |
K902853 |
| Device Name |
GRAVITY PLUS CONTROLLER/COMPOUNDER |
| Applicant |
| Fergy Corp. |
| Dba Pie |
| 1300 E. Main St. |
|
Grass Valley,
CA
95945
|
|
| Applicant Contact |
DAVE STOKES |
| Correspondent |
| Fergy Corp. |
| Dba Pie |
| 1300 E. Main St. |
|
Grass Valley,
CA
95945
|
|
| Correspondent Contact |
DAVE STOKES |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 06/29/1990 |
| Decision Date | 05/09/1991 |
| 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
|
|
|