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
|
|
|