The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for Empty Mixing Container.
| Device ID | K932641 |
| 510k Number | K932641 |
| Device Name: | 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 |
|---|---|---|
| 10816415020543 | K932641 | 000 |
| 10816415020536 | K932641 | 000 |
| 10816415020529 | K932641 | 000 |
| 10816415020475 | K932641 | 000 |
| 10816415020468 | K932641 | 000 |
| 10816415020437 | K932641 | 000 |
| 10816415020352 | K932641 | 000 |
| 10816415020321 | K932641 | 000 |