Device Classification Name |
pump, infusion
|
510(k) Number |
K042432 |
Device Name |
PHARMGUARD TOOLBOX, MODEL G6000782 |
Applicant |
MEDEX, INC. |
6250 SHIER RINGS RD. |
DUBLIN,
OH
40316
|
|
Applicant Contact |
BARBARA LAW |
Correspondent |
MEDEX, INC. |
6250 SHIER RINGS RD. |
DUBLIN,
OH
40316
|
|
Correspondent Contact |
BARBARA LAW |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/08/2004 |
Decision Date | 01/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|