The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Eva Empty Mixing Container.
Device ID | K932640 |
510k Number | K932640 |
Device Name: | EVA EMPTY MIXING CONTAINER |
Classification | Container, I.v. |
Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Contact | Douglas Johnson |
Correspondent | Douglas Johnson DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Product Code | KPE |
CFR Regulation Number | 880.5025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-02 |
Decision Date | 1993-11-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10816415020697 | K932640 | 000 |
10816415020376 | K932640 | 000 |
10816415020482 | K932640 | 000 |
10816415020499 | K932640 | 000 |
10816415020505 | K932640 | 000 |
10816415020512 | K932640 | 000 |
10816415020550 | K932640 | 000 |
10816415020567 | K932640 | 000 |
10816415020574 | K932640 | 000 |
10816415020659 | K932640 | 000 |
10816415020666 | K932640 | 000 |
10816415020673 | K932640 | 000 |
10816415020680 | K932640 | 000 |
10816415020369 | K932640 | 000 |