The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Ez-mio Distal Tibia, Ez-io Distal Tibia, Vidaport Intraosseous Infusion System, Ez-io.
| Device ID | K091140 |
| 510k Number | K091140 |
| Device Name: | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvin, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvin, CA 92606 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816000013732 | K091140 | 000 |