SAM IO Intraosseous Access System

Needle, Hypodermic, Single Lumen

SAM® Medical Products, Inc.

The following data is part of a premarket notification filed by Sam® Medical Products, Inc. with the FDA for Sam Io Intraosseous Access System.

Pre-market Notification Details

Device IDK191488
501k NumberK191488
Device Name:SAM IO Intraosseous Access System
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SAM® Medical Products, Inc. 27350 SW 95th Ave, Suite 3038 Wilsonville,  OR  97070
ContactJeff Lipps
CorrespondentMichelle Lott
Lean RAQA, LLC 12602 North Summerwind Drive Marana,  AZ  85658
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-11-21

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