The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for Powered Ez-io Pediatric Bone Marrow Aspiration System.
| Device ID | K070759 |
| 510k Number | K070759 |
| Device Name: | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM |
| Classification | Instrument, Biopsy, Mechanical, Gastrointestinal |
| 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 | FCF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2007-05-21 |
| Summary: | summary |