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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 K191976
Device Name Piper GO-IO Intraosseous Infusion System
Applicant
Piper Access, LLC
3981 S. 700 E. Suite #15
Salt Lake City,  UT  84107
Applicant Contact Jacob Lee
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/24/2019
Decision Date 11/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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