The following data is part of a premarket notification filed by Piper Access, Llc with the FDA for Piper Go-io Intraosseous Infusion System.
| Device ID | K191976 |
| 510k Number | K191976 |
| Device Name: | Piper GO-IO Intraosseous Infusion System |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Piper Access, LLC 3981 South 700 East Suite #15 Salt Lake City, UT 84107 |
| Contact | Jacob Lee |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-07-24 |
| Decision Date | 2019-11-13 |