Device Classification Name |
Shunt, Central Nervous System And Components
|
510(k) Number |
K033017 |
Device Name |
PHOENIX INFUSION CATHETER |
Applicant |
PHOENIX BIOMEDICAL |
PO BOX 80390 |
2495 GENERAL ARMISTEAD AVE |
VALLEY FORGE,
PA
19484
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
PHOENIX BIOMEDICAL |
PO BOX 80390 |
2495 GENERAL ARMISTEAD AVE |
VALLEY FORGE,
PA
19484
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 09/26/2003 |
Decision Date | 04/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|