Device Classification Name |
pump, infusion
|
510(k) Number |
K930459 |
Device Name |
BARD MINI-INFUSER 1500 & 3000 |
Applicant |
BARD MEDSYSTEMS DIV. |
87 CONCORD ST. |
NORTH READING,
MA
01864
|
|
Applicant Contact |
BRUCE W HUSEL |
Correspondent |
BARD MEDSYSTEMS DIV. |
87 CONCORD ST. |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
BRUCE W HUSEL |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 01/28/1993 |
Decision Date | 08/10/1993 |
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
|
|
|