Device Classification Name |
pump, infusion
|
510(k) Number |
K902613 |
Device Name |
BARD PCA II PUMP WITH PROGRAM CARTRIDGES |
Applicant |
C.R. BARD, INC. |
87 CONCORD RD. |
NORTH READING,
MA
01864
|
|
Applicant Contact |
ERIC P ANKERUD |
Correspondent |
C.R. BARD, INC. |
87 CONCORD RD. |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
ERIC P ANKERUD |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 06/13/1990 |
Decision Date | 04/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|