The following data is part of a premarket notification filed by Metrix Co. with the FDA for Eva Empty Solution Container.
Device ID | K030888 |
510k Number | K030888 |
Device Name: | EVA EMPTY SOLUTION CONTAINER |
Classification | Container, I.v. |
Applicant | METRIX CO. 4400 CHAVENELLE RD. Dubuque, IA 52002 |
Contact | James J Oldham |
Correspondent | James J Oldham METRIX CO. 4400 CHAVENELLE RD. Dubuque, IA 52002 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-21 |
Decision Date | 2003-04-02 |