Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K991513 |
Device Name |
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO |
Applicant |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
ROBERT J BARD |
Correspondent |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
ROBERT J BARD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/30/1999 |
Decision Date | 06/21/1999 |
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
|
Recalls |
CDRH Recalls
|
|
|