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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Interosseous
510(k) Number K223198
Device Name BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
Applicant
Bard Access Systems
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Nasreen Al-Quaid
Correspondent
Bard Access Systems
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Nasreen Al-Quaid
Regulation Number880.5570
Classification Product Code
MHC  
Date Received10/13/2022
Decision Date 11/10/2022
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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