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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K231924
Device Name EZ-IO Intraosseous Vascular Access System
Applicant
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Applicant Contact Rachel Rehl
Correspondent
Teleflex Medical
3015 Carrington Mill Blvd.
Morrisville,  NC  27560
Correspondent Contact Rachel Rehl
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/30/2023
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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