FDA 510(k) Application Details - K163388

Device Classification Name	More FDA Info for this Device
510(K) Number	K163388
Device Name	XPress BCD Breast Compression Device
Applicant	XPress BCD, LLC 6024 White Flint Drive Frederick, MD 21702 US Other 510(k) Applications for this Company
Contact	Peter Kremers Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2016
Decision Date	07/19/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review