Device Classification Name |
Pump, Infusion, Elastomeric
|
510(k) Number |
K040337 |
Device Name |
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) |
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 | 02/11/2004 |
Decision Date | 05/24/2004 |
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
|
|
|