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510(k) K192948

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G by Bard Peripheral Vascular, Inc. — Product Code KNW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 7, 2019
Date Received: October 18, 2019
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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