The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Texium Syringe.
| Device ID | K071108 |
| 510k Number | K071108 |
| Device Name: | TEXIUM SYRINGE |
| Classification | Syringe, Piston |
| Applicant | CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Contact | Stacy L Lewis |
| Correspondent | Stacy L Lewis CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego, CA 92121 -2772 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-19 |
| Decision Date | 2007-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885403230521 | K071108 | 000 |
| 50885403221697 | K071108 | 000 |
| 50885403221680 | K071108 | 000 |
| 50885403221673 | K071108 | 000 |
| 50885403221666 | K071108 | 000 |
| 50885403221659 | K071108 | 000 |