Piper GO-IO Intraosseous Infusion System

Needle, Hypodermic, Single Lumen

Piper Access, LLC

The following data is part of a premarket notification filed by Piper Access, Llc with the FDA for Piper Go-io Intraosseous Infusion System.

Pre-market Notification Details

Device IDK191976
501k NumberK191976
Device Name:Piper GO-IO Intraosseous Infusion System
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Piper Access, LLC 3981 South 700 East Suite #15 Salt Lake City,  UT  84107
ContactJacob Lee
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
3rd Party ReviewedYes
Combination ProductNo
Date Received2019-07-24
Decision Date2019-11-13

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