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510(k) K211933

EleVation Breast Biopsy System by Bard Peripheral Vascular — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2021
Date Received
June 22, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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