The following data is part of a premarket notification filed by Einstein Works, L.l.c. with the FDA for Intraosseous Infusion Device.
| Device ID | K191258 |
| 510k Number | K191258 |
| Device Name: | Intraosseous Infusion Device |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Einstein Works, L.L.C. 5312 Elm Street Houston, TX 77081 |
| Contact | Linda Taylor |
| Correspondent | David Makanani OMEDtech, L.L.C. 1725 SIgnal Ridge Drive, Suite 150 Edmond, OK 73013 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850026832003 | K191258 | 000 |