Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K043456 |
Device Name |
MODIFICATION TO SOAKER CATHETER |
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 | 868.5120
|
Classification Product Code |
|
Date Received | 12/15/2004 |
Decision Date | 01/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|