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510(k) K191976

Piper GO-IO Intraosseous Infusion System by Piper Access, LLC — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2019
Date Received
July 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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