Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K935811 |
Device Name |
BOLUS DISPENSER |
Applicant |
I-FLOW CORP. |
2532 WHITE RD. |
IRVINE,
CA
92714
|
|
Applicant Contact |
ROBERT J BARD |
Correspondent |
I-FLOW CORP. |
2532 WHITE RD. |
IRVINE,
CA
92714
|
|
Correspondent Contact |
ROBERT J BARD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/02/1993 |
Decision Date | 01/20/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|