Device Classification Name |
shunt, central nervous system and components
|
510(k) Number |
K024101 |
Device Name |
PHOENIX UNIVERSAL SHUNT SYSTEM |
Applicant |
PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Applicant Contact |
COURTNEY SMITH |
Correspondent |
PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. |
NORRISTOWN,
PA
19403
|
|
Correspondent Contact |
COURTNEY SMITH |
Regulation Number | 882.5550
|
Classification Product Code |
|
Date Received | 12/12/2002 |
Decision Date | 01/27/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|