| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K896075 |
| Device Name |
CADD-PCA AMBULATORY INFUSION PUMPS |
| Applicant |
| Pharmacia Deltec, Inc. |
| 1265 Grey Fox Rd. |
|
St. Paul,
MN
55112
|
|
| Applicant Contact |
W NUMAINVILLE |
| Correspondent |
| Pharmacia Deltec, Inc. |
| 1265 Grey Fox Rd. |
|
St. Paul,
MN
55112
|
|
| Correspondent Contact |
W NUMAINVILLE |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 10/19/1989 |
| Decision Date | 08/21/1990 |
| 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
|
|
|