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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K213896
Device Name BD Trek Powered Bone Biopsy System
Applicant
Bard Peripheral Vascular
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Courtney Willson
Correspondent
Bard Peripheral Vascular
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Kristen Dejeu
Regulation Number876.1075
Classification Product Code
KNW  
Date Received12/14/2021
Decision Date 03/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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