The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Ez-mio Sternal.
| Device ID | K063567 |
| 510k Number | K063567 |
| Device Name: | EZ-MIO STERNAL |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland VIDACARE CORPORATION 3722 AVE. SAUSALITO Irvine, 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 | 2006-11-28 |
| Decision Date | 2007-01-26 |
| Summary: | summary |