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 |