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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 K211933
Device Name EleVation Breast Biopsy System
Applicant
Bard Peripheral Vascular
1625 W. 3rd Street
Tempe,  AZ  85281
Applicant Contact Meghan McKelvey
Correspondent
Bard Peripheral Vascular
1625 W. 3rd Street
Tempe,  AZ  85281
Correspondent Contact Meghan McKelvey
Regulation Number876.1075
Classification Product Code
KNW  
Date Received06/22/2021
Decision Date 07/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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