| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K863683 |
| Device Name |
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP |
| Applicant |
| C.R. Bard, Inc. |
| 111 Spring St. |
|
Murray Hill,
NJ
07974
|
|
| Applicant Contact |
JOSEPH KICEINA |
| Correspondent |
| C.R. Bard, Inc. |
| 111 Spring St. |
|
Murray Hill,
NJ
07974
|
|
| Correspondent Contact |
JOSEPH KICEINA |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 09/19/1986 |
| Decision Date | 10/07/1986 |
| 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
|
|
|