The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxject Ii.
| Device ID | K042410 |
| 510k Number | K042410 |
| Device Name: | BAXJECT II |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
| Contact | Ron Lagerquist |
| Correspondent | Ron Lagerquist BAXTER HEALTHCARE CORP. ONE BAXTER WAY Westlake Village, CA 91362 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2004-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50642621003944 | K042410 | 000 |