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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 K240915
Device Name ZIEN IO Intraosseous Access System
Applicant
Zien Medical Technologies, Inc.
2490 S. 300 W
Salt Lake City,  UT  84115
Applicant Contact Tim Nieman
Correspondent
Zien Medical Technologies, Inc.
2490 S. 300 W
Salt Lake City,  UT  84115
Correspondent Contact Tim Nieman
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/03/2024
Decision Date 07/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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