Device Classification Name |
container, i.v.
|
510(k) Number |
K030888 |
Device Name |
EVA EMPTY SOLUTION CONTAINER |
Applicant |
METRIX CO. |
4400 CHAVENELLE RD. |
DUBUQUE,
IA
52002
|
|
Applicant Contact |
JAMES J OLDHAM |
Correspondent |
METRIX CO. |
4400 CHAVENELLE RD. |
DUBUQUE,
IA
52002
|
|
Correspondent Contact |
JAMES J OLDHAM |
Regulation Number | 880.5025
|
Classification Product Code |
|
Date Received | 03/21/2003 |
Decision Date | 04/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|