Device Classification Name |
Pump, Infusion, Elastomeric
|
510(k) Number |
K023318 |
FOIA Releasable 510(k) |
K023318
|
Device Name |
I-FLOW ELASTOMERIC PUMP WITH BOLUS |
Applicant |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
SHANE NOEHRE |
Correspondent |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
SHANE NOEHRE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 10/04/2002 |
Decision Date | 10/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|