K-number	K163388
Device name	XPress BCD Breast Compression Device
Applicant	Xpress Bcd, LLC
Product code	POY
Device class	Class II
Decision date	Jul 19, 2017
Decision	Substantially Equivalent
Regulation	892.1710

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Source

View the full FDA submission: accessdata.fda.gov

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XPress BCD Breast Compression Device

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