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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 K203193
Device Name BD Intraosseous Infusion System
Applicant
Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD]
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Connor Dahl
Correspondent
Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD]
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Connor Dahl
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/28/2020
Decision Date 03/04/2021
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
Recalls CDRH Recalls
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