The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for All-in-one Container.
| Device ID | K090096 |
| 510k Number | K090096 |
| Device Name: | ALL-IN-ONE CONTAINER |
| Classification | Container, I.v. |
| Applicant | BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Nanette Hedden |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-15 |
| Decision Date | 2009-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412043864 | K090096 | 000 |
| 50085412042126 | K090096 | 000 |
| 50085412041419 | K090096 | 000 |