K-number	K103512
Device name	AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Applicant	Hologic, Inc.
Product code	IZH
Device class	Class II
Decision date	Jan 7, 2011
Decision	Substantially Equivalent
Regulation	892.1710

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View the full FDA submission: accessdata.fda.gov

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AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

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