Device Classification Name |
Pump, Infusion, Elastomeric
|
510(k) Number |
K991543 |
FOIA Releasable 510(k) |
K991543
|
Device Name |
INTRAOP CATHETER |
Applicant |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Applicant Contact |
STANLEY E FRY |
Correspondent |
I-FLOW CORP. |
20202 WINDROW DR. |
LAKE FOREST,
CA
92630
|
|
Correspondent Contact |
STANLEY E FRY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/03/1999 |
Decision Date | 10/25/1999 |
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
|
|
|