Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K984441 |
Device Name |
KVO CHECK VALVE ACCESSORY, MODEL EV-0001 |
Applicant |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
SHANE P NOEHRE |
Correspondent |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
SHANE P NOEHRE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/14/1998 |
Decision Date | 02/22/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|