K-number	K161575
Device name	Affirm Lateral Arm Upright Biopsy Accessory
Applicant	Hologic
Product code	IZH
Device class	Class II
Decision date	Aug 10, 2016
Decision	Substantially Equivalent
Regulation	892.1710

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Source

View the full FDA submission: accessdata.fda.gov

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Affirm Lateral Arm Upright Biopsy Accessory

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