The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Smartsite Vented Vial Access Device, Model Tbd.
| Device ID | K052790 |
| 510k Number | K052790 |
| Device Name: | SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD |
| Classification | Set, I.v. Fluid Transfer |
| 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 | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2005-12-23 |
| Summary: | summary |