The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Disposable Intraosseous Infusion Needle.
| Device ID | K930217 |
| 510k Number | K930217 |
| Device Name: | BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Contact | Jan Robertson |
| Correspondent | Jan Robertson BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-15 |
| Decision Date | 1994-02-28 |