| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K896717 |
| Device Name |
PARTNER INFUSION SYSTEM: |
| Applicant |
| Q-Life Systems, Inc. |
| 1180 Clyde Ct. |
|
Kingston, Ontario,
CA
K7P 2E4
|
|
| Applicant Contact |
TIMOTHY SMITH |
| Correspondent |
| Q-Life Systems, Inc. |
| 1180 Clyde Ct. |
|
Kingston, Ontario,
CA
K7P 2E4
|
|
| Correspondent Contact |
TIMOTHY SMITH |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 11/29/1989 |
| Decision Date | 08/02/1990 |
| 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
|
|
|