K-number	K180233
Device name	Eviva Stereotactic Guided Breast Biopsy System
Applicant	Hologic, Inc.
Product code	KNW
Device class	Class II
Decision date	Apr 10, 2018
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Eviva Stereotactic Guided Breast Biopsy System

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