The following data is part of a premarket notification filed by Vidacare Corporation with the FDA for The T.a.l.o.n. Intraossous Infusion System By Vidacre.
| Device ID | K120661 |
| 510k Number | K120661 |
| Device Name: | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE |
| 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 | 2012-03-05 |
| Decision Date | 2012-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30816000012483 | K120661 | 000 |
| 30816000013855 | K120661 | 000 |